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TABLE OF CONTENTS

Incubation Service Types ………………………………………...…...….. Page 3

Business Activities by Department . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ... Page 5

Product Development Activities by Phase ……………………………… Page 7

Workforce Services ………………………………………………………. Page 8

SYSTEMS Access & Use Services ………………………………………... Page 15

Assets Accessible with SYSTEMS Access & Use ……………….……….. Page 16

EQUIPMENT Access & Use Services ………………………………........ Page 17

Assets Accessible with EQUIPMENT Access & Use ……….………….. Page 18

NMDDO Facility Map ……………………………………………......…. Page 19


INCUBATION SERVICE TYPES FULLY INCUBATED ELEVATOR This type of client utilizes all Naglreiter’s service types including creation and maintenance of the client’s quality system, full Initial Equipment Access and Use, and Workforce Services for all departments. This is the highest level of service Naglreiter provides where the client’s company is created and administered fully in Naglreiter’s facility and utilizing Naglreiter’s associates. The client remains the spec developer and manufacturer, but all certified activity is conducted in the Naglreiter facility utilizing Naglreiter associates for as much of the activity as the client needs. Defining characteristics for a fully incubated company:

◼ Legal Spec developer - client ◼ Legal Manufacturer - client ◼ Location of services - Naglreiter ◼ Type of Budget – COP (Company Operating Plan) ◼ Workforce Services – All levels and departments ◼ System A&U – At least one INI ◼ EQMT A&U - At least one INI ◼ Which QMS/BIZ - Client (Created/Administered by Naglreiter)

PARTIALLY INCUBATED ELEVATOR (SPEC DEVELOPER) This type of client has development projects that may require systems, equipment and workforce services, but at a lower level than a fully incubated client. The client is the spec developer and manufacturer and the client company is not being fully created or maintained by Naglreiter. The client company is only partially incubated for the purposes of running a development project. Development projects are conducted either in the client’s own quality system (administered by them that Naglreiter associates work within) or in the Naglreiter QMS. The client will not be provided with its own quality system. The client will be provided with the equipment services, but all annual EQMT requirements are conducted under the Naglreiter system. The EQMT access and use requirement is reduced. Defining characteristics for a partially incubated (spec developer) company:

◼ Legal Spec developer - client ◼ Legal Manufacturer - client ◼ Location of services - Naglreiter ◼ Type of Budget – BGT (Project Budget) ◼ Workforce Services – Program management and below ◼ System A&U – No INI, only SUB ◼ EQMT A&U - No INI, only SUB ◼ Which QMS/BIZ – Client (we work in client system) or Naglreiter


PARTIALLY INCUBATED ELEVATOR (CONTRACT MANUFACTURER)

This type of client has contract manufacturing needs that may require systems, equipment and workforce services, but at a lower level than a fully incubated client. The client is the spec developer and manufacturer and the client company is not being fully created or maintained by Naglreiter. The client company is only partially incubated for the purposes of running manufacturing in the Naglreiter facility. The manufacturing activity is conducted either in the client’s own quality system (administered by them that Naglreiter associates work within) or in the Naglreiter QMS. The client will not be provided with its own quality system. The client will be provided with the equipment services, but all annual EQMT requirements are conducted under the Naglreiter system. The EQMT access and use requirement is reduced. Defining characteristics for a partially incubated (contract manufacturer) company:

◼ Legal Spec developer - client ◼ Legal Manufacturer - client ◼ Location of services - Naglreiter ◼ Type of Budget – BGT (Project Budget) ◼ Workforce Services – Program management and below ◼ System A&U – None (using Client’s QMS), or SUB (mfg at Naglreiter MFG under

Naglreiter same QMS) ◼ EQMT A&U – No INI, only SUB ◼ Which QMS/BIZ - Client (we work in client system), or Naglreiter Manufacturing

NON-INCUBATED (TRADITIONAL CONSULTING) This type of client has product development needs that may require systems, and workforce services, but at a much lower level than a fully incubated client. The client is the spec developer and manufacturer and the client company is not being fully created or maintained by Naglreiter. The client company is not incubated at Naglreiter and any physical services are conducted at the client facility. The activity is conducted either in the client’s own quality system (administered by them that Naglreiter associates work within) or in the Naglreiter QMS. The client will not be provided with its own quality system. The client will not be provided with the equipment services. Defining characteristics for a non-incubated (traditional consulting) company:

◼ Legal Spec developer - client ◼ Legal Manufacturer - client ◼ Location of services - client ◼ Type of Budget – BGT (Project Budget) ◼ Workforce Services – Program management and below ◼ System A&U – None or SUB ◼ EQMT A&U – None ◼ Which QMS/BIZ - Client (we work in client system), or Naglreiter


BUSINESS ACTIVITIES BY DEPARTMENT

Department

Code

Department

Name Potential Department Activities

EXEC Executive

▪ Company name and branding approval

▪ Place of business selection

▪ Type of company / state of incorporation selection

▪ Tax status selection

▪ Management type selection (directors, managers /

board)

▪ Charter / incorporation documents / operating

agreement approval

▪ Corporate secretary obligations

▪ Company internal organization (Business Manual)

▪ Management selection / organization chart management

▪ Company vision and mission statements

▪ 5-year business objectives, strategies, and company

operating plan (COP)

▪ Overall business milestone approval for all departments

▪ Overall company operating plan (COP) and financial

statement approval

▪ Overall financial health responsibility

▪ Fundraising activities

▪ Internal and external company communications

▪ Advisory board selection

MKTG Sales and

Marketing

▪ Sales and Marketing specific business milestones

and metrics

▪ Sales and Marketing specific departmental budget

▪ Sales and Marketing departmental organization and

resource selection

▪ Sales and Marketing internal communication

obligations to the executive team

▪ Revenue forecasting obligations

▪ Revenue generation obligations

▪ Customer contract management

▪ Sales training activities

▪ Customer service obligations

▪ Sales management and field support responsibilities

▪ Trade-show activities

▪ Customer relationship management

▪ Voice of the Customer data acquisition

ACCT Accounting

▪ Accounting specific business milestones and metrics

▪ Accounting specific departmental budget

▪ Accounting specific departmental organization and

resource selection

▪ Accounting internal communication obligations to

the executive team

▪ Company governmental registration activities

▪ Banking activities

▪ Financial software management (chart of accounts)

▪ Departmental and project budget oversight

▪ Company operating plan and financial reporting

management and oversight

▪ Accounts payable activities

▪ Accounts receivable activities

▪ Payroll (including commission reports) activities

▪ Tax activities (sales, payroll, company)

▪ Travel expense report obligations

▪ Sales invoicing activities

▪ Non-consultant supplier contract management

▪ Credit card management

▪ Purchase order system management

▪ Capital asset value management

▪ Liability insurance management

▪ Property insurance management

SYST Systems

▪ System specific business and quality milestones and

metrics

▪ System specific business and quality departmental

budgets

▪ System specific business and quality organization and

resource selection

▪ System internal communication obligations to the

executive team

▪ The system department is responsible for creation,

implementation, maintenance, and termination of

the overall company business system including the

following departmental specific subsystems:

▪ Business Manual (EXEC)

▪ Accounting Procedures (ACCT)

▪ Asset Review and Disposition (EQMT)

▪ Associate Lifecycle Management Including Access to

HR Management software (WFMT)

▪ Business Systems Training (SYST)

▪ Company Profile Management (EXEC)

▪ Company Travel Policy (ACCT)

▪ IT Services - Cloud Server Policy (EQMT)

▪ IT Services – Double Robot (EQMT)

▪ IT Services – General (EQMT)

▪ IT Services - Server Backup Policy (SYST)

▪ Legal Activities (EXEC)

▪ The system department is responsible for creation,

implementation, maintenance, regulatory compliance, and

termination of the Quality Management System including

the following departmental specific elements:

▪ Quality Manual and scope (SYST)

▪ Associate Conduct (WFMT)

▪ Control of Monitoring and Measuring Devices (EQMT)

▪ Documentation control (SYST)

▪ General Safety Practices (EQMT)

▪ Purchasing Control including access to ERP Management

software for POs (SYST)

▪ Tooling Control (EQMT)

▪ Safety and Health Policy (WFMT)

▪ Canadian Medical Device Licensing (SYST)

▪ Canadian Medical Device Problem Reporting (SYST)

▪ Complaint Handling (SYST)

▪ Control of Nonconforming product (SYST)

▪ Corrective and Preventive action (SYST)

▪ Design and Development (PLMT)

▪ Equipment, Process and Product Validation (PLMT)

▪ Identification and Traceability (PLMT)

▪ Internal audit (SYST)

▪ Management Review (SYST)

▪ Market Studies and Clinical trials (PLMT)

▪ Measurement Analysis and Improvement (SYST)


▪ Project Lifecycle Management (PLMT)

▪ Receiving of Visitors (EQMT)

▪ Documentation Standards (SYST)

▪ Employee Performance Review (WFMT)

▪ Information Security (SYST)

▪ Project Archiving Process (EQMT)

▪ Shipping Procedure (EQMT)

▪ Medical Device Reporting (SYST)

▪ Medical Device Vigilance System (SYST)

▪ Monitoring and Measurement of Product (PLMT)

▪ Natural Disaster Plan (EQMT)

▪ Pest Control (EQMT)

▪ Production and Service Provision (PLMT)


software for Material Management and Sales Orders

(MKTG)

▪ Record control (SYST)

▪ Risk Management (PLMT)

▪ Sales Contract Review and Sales Order Initiation (MKTG)

▪ Sales Order Processing and Shipping (PLMT)

▪ Supplier Rating System (non-consultants and service

suppliers) (SYST)

▪ Supplier Relations (SYST)

▪ Technical Documentation (PLMT)

▪ Training (SYST)

▪ Verification of purchased product (PLMT)

EQMT Equipment

and Facilities

▪ Equipment and facility specific business milestones

and metrics

▪ Equipment and facility specific departmental budget

▪ Equipment and facility specific departmental

organization and resource selection

▪ Equipment and facility internal communication


▪ Non-consumable asset management obligations

including IT hardware and software

▪ Asset and tool calibration system obligations

▪ Asset and tool preventive maintenance system

obligations

▪ Facility obligations (office, front desk, breakroom,

environmentally controlled rooms, prototyping area,

warehousing)

▪ Facility cleaning and maintenance activities including pest

control

▪ Asset archiving activities

▪ Consumable inventory management activities

▪ Information technology obligations activities (Help Desk)

▪ Determination of hours of operation and annual business

calendar

▪ Visitor login and security system obligations

▪ Receiving and Shipping Activities

▪ Equipment and facility planning and forecasting including

utility service requirements

WFMT Workforce

Management

▪ Workforce management specific business milestones

and metrics

▪ Workforce management specific departmental

budget

▪ Workforce management specific departmental


▪ Workforce management internal communication


▪ Associate profile database and relevant human

resource software

▪ Associate benefit package management

▪ Social and cultural activities

▪ Retention policies and packages

▪ Recruiting activities

▪ Onboarding and offboarding activities

▪ Associate performance review process

▪ Staffing plan and forecasting

▪ Addressing workplace issues

▪ Internship program management

▪ Survey associate satisfaction

PLMT Project

Lifecycle

Management

▪ Project lifecycle management specific business

milestones and metrics

▪ Project lifecycle management specific departmental

budget

▪ Project lifecycle management specific departmental


▪ Project lifecycle management internal

communication obligations to the executive team

▪ Project name determination

▪ Project code determination

▪ Project design and development plans

▪ Project budgeting and scheduling activities

▪ Project role authorizations for (R&D, OPS, QA/RA,

Marketing, Executive)

▪ Project organizational chart

▪ Project execution obligation in all phases

▪ Project information storage needs and locations

▪ Project facility resources needs

▪ Project tracking and management based on risk mitigations

tools


PRODUCT DEVELOPMENT ACTIVITIES BY PHASE

Design

Phase

Phase

Description Potential Phase Activities

A Proof of

Concept

▪ Technology Evaluation

▪ Financial Review

▪ Market Analysis

▪ Competitive Assessment

▪ Initial Marketing Specification (MTS)

▪ Early Risk Assessment

▪ IP Analysis

▪ Regulatory / Clinical Path

▪ Reimbursement Path

I Definition &

Feasibility

▪ Market Specification (MTS) and other design inputs

▪ Product Specification (PRS)

▪ Legal Issues

▪ Produce and test functional prototypes

▪ Product/procedure preliminary risk analysis

▪ MDRs/complaints/failures and/or other historical

and/or marketing data.

▪ PDT Team Roster

▪ Marketing Strategy

▪ Regulatory and Clinical Strategy

▪ Supplier development plan

▪ Biocompatibility test plan

▪ Processes required to manufacture product

▪ Manufacturing process Ergonomic, health,

safety, and environmental issues.

▪ Design plan

▪ Risk Management Plan

▪ Target average sales price and margin

II Design &

Development

▪ Adjusted PDT Roster

▪ Continue prototype design evaluation

▪ Biocompatibility testing

▪ Market evaluations (as applicable)

▪ Market evaluation feedback (as applicable)

▪ Revised market specification (MTS) (if needed)

▪ Revised product specification (PRS) (if needed)

▪ Revised design plan (if needed)

▪ Update risk analysis

▪ Labeling/Packaging development

▪ Manufacturing process documentation/Control Plan

▪ Validation Plan

▪ Sterilization method development and validation

Develop initial design outputs

▪ Tool qualification for DV and lot release

tooling, as determined by the Validation Plan

▪ Equipment to be calibrated

▪ Complete initial Design Verification

▪ Complete Initial Design Validation

▪ Manufacturing scale-up /production release

resource requirements

▪ Process, ergonomic, health, safety and

environmental issues

▪ Accelerated/real time aging, if possible

▪ Conduct supplier evaluation/approval

activities per Design Plan requirements

▪ Address all open action items from previous

design reviews

III Validation

▪ Train and certify employees to manufacturing and

quality processes

▪ Tool Qualification, as determined by the Validation

Plan

▪ Process, Product Validations and reports

▪ Perform Accelerated Aging

▪ Real Time Aging Protocol

▪ Design Change review

▪ Complete final Design Verification

▪ Complete final Design Validation

▪ Final Risk Management Report

▪ Market Evaluations (as applicable)

▪ Market Evaluation feedback (as applicable)

▪ Regulatory submission approval or

concurrence as required or "Letter to File"

▪ Response to process, ergonomic, health, safety,

and environmental issues

▪ Final review of design plan, market

specification and product specification

▪ Conduct supplier evaluation/approval

activities per Design Plan requirements

▪ Address all open action items from previous

design reviews

▪ Final design outputs

P Production

▪ Ongoing Production / Operations support

▪ Physician Training & cont’d sales effort

▪ Product improvements, as needed

▪ Post-market Surveillance / MDR

▪ Process Improvements, as needed

▪ Update Design Control Docs, as needed

▪ Quality Audits

▪ Continued Clinical Validation

T Transfer

▪ DHF transfer

▪ DMR transfer

▪ On-site training

▪ Supplier re-qualification support

▪ Production qualification support

▪ Ongoing design & process support

▪ Ongoing production support


WORKFORCE SERVICES

Catalog Code Description Details

Management

WFS-EIR Entrepreneur-In-

Residence

▪ Provides macro perspective for organizational decision-making, and comprehensive

leadership across multiple organizational disciplines in the face of evolving market

dynamics, technical landscape changes, and financial realities

▪ Crafts and champions company vision throughout the organization including real-world

implementation of the vision

▪ Plans and raises the capital required to keep company initiatives moving forward

▪ Primary organizational liaison to Board

WFS-COO Chief Operating

Officer

▪ Directs and leads the planning and allocation of resources across all operating departments in

support of organizational business and technical objectives

▪ Partners with executive management on key planning strategies and makes

recommendations on critical executive-level decisions

▪ Serves as second-in-command in the organization and thought partner for EIR

WFS-DIR-PGM Program Director

All of the below plus ▪ Plans the delivery of an overall program portfolio and the required activities in accordance

with the mission and the goals of the organization

▪ Develops budgets and operating plans to support program portfolio annually, as well as when

required, throughout the life of the portfolio

▪ Leads program teams and facilitates communication and interaction among the functional

representatives

WFS-MGR-PGM Program Manager

All of the below plus ▪ Tracks program against budget, time schedule and phase review objectives, reporting status

to supervisor and executive staff as necessary

▪ Identifies program risk and implements mitigation within time and budget constraints –

develops and implements recovery plan for off-schedule or unanticipated events

▪ Serves as liaison with stakeholders, including management and boards

WFS-MGR-PJT Project Manager

▪ Ensures that the right product is developed to meet or exceed quality standards

▪ Develops project goals, objectives and plans for effective project completion

▪ Assembles, coordinates and manages multidisciplinary technical reviews

▪ Coordinates with customers to secure their feedback throughout development

Design Engineering

WFS-DES-PRF Principal Fellow

Design Engineer

All of the below plus ▪ Deep practical expertise in a particular specialty

▪ Advanced degree, additional credentials or fellowship experience in specific technical area

WFS-DES-PRN Principal Design

Engineer

All of the below plus ▪ Plans and formulates engineering program and organizes project staff according to project

requirements

▪ Assigns project personnel to specific phases or aspects of project such as technical studies,

product design, preparation of specifications and technical plans, and product testing

▪ Designs, models, and tests prototypes for products and provides production support to

machining and assembly areas

WFS-DES-SNR Senior Design

Engineer

All of the below plus ▪ Produces test procedures, and engineering reports, documents and manuals

▪ Analyzes and solves technical problems and provides solutions in timely manner

▪ Contacts customers and suppliers for technical support of project managers

▪ Leads root cause analysis to evaluate device failure in testing of field complaints

WFS-DES Design Engineer

▪ All of the below plus ▪ Analyzes engineering sketches, specifications and related data and drawings to determine

design factors such as size, shape and arrangement of parts

▪ Reviews product design for compliance with engineering principles, company standards and

customer contract requirements and related specifications

▪ Measures parts during production to ensure compliance with design specifications

WFS-SMD-PRN Principal Solid

Model Designer

▪ Uses computer assisted design / drafting (SolidWorks, CAD) equipment and software to

develop product designs

▪ Creates and revises product drawings (detail and assembly drawings)

▪ Establishes and maintains an organized file system for product drawings



Development Engineering

WFS-PDE-PRF

Principal Fellow

Product

Development

Engineer



WFS-PDE-PRN

Principal Product

Development

Engineer

All of the below plus ▪ Authors and executes product and system specifications, validation and test protocols and

validation and test reports

▪ Leads or plays a prominent role supporting Risk Management activities including, Fault Tree

Analysis and Failure Mode and Effects Analysis activities to ensure design, use, and process

shortcomings are identified and addressed

▪ Identifies Design Outputs at component and sub-assembly levels for product to ensure

compliance with product specifications

WFS-PDE-SNR

Senior Product

Development

Engineer

All of the below plus ▪ Evaluates the feasibility of concepts and/or prototypes through engineering testing and

analysis, consistent with customer expectations

▪ Works with QA and R&D to maintain an approved Quality System that complies with GMP,

QSR and ISO standards

▪ Supports QA and RA in drafting 510k submissions for market clearance

▪ Identifies Design Outputs at component and sub-assembly levels for product to ensure

compliance with product specifications

WFS-PDE

Product

Development

Engineer

All of the below plus ▪ Designs, develops and prototypes new products in accordance with company Project

Lifecycle Management (PLM) requirements

▪ Evaluates, documents, and implements potential design and process changes to improve

product performance, manufacturability, safety or cost consistent with GMP or company

PLM process

▪ Oversees testing and theoretical analysis of products to determine product safety and efficacy

Development Technicians

WFS-TEC-PRN Principal

Technician

All of the below plus ▪ Designs, develops builds and tests new products or improvements to current products using

best practices following design input from engineering

▪ Provides technical feedback during product and process development to increase reliability

and/or repeatability based on previous knowledge

WFS-TEC-SNR Senior Technician

All of the below plus ▪ Provides support to manufacturing representatives and ensures functionality of all production

equipment ▪ Improves production lines, manufacturing equipment and processes with direction from

engineering and production management to ensure product quality

WFS-TEC Technician

▪ Collaborates with development team and operates testing equipment to perform and

implement testing on new products, or improvements to current products

▪ Conducts manufacturing, quality control and R&D tasks per approved operational procedures,

or as defined by the requestor of the tasks

Regulatory Affairs

WFS-REG-STR Regulatory Affairs

Strategic Advisor

All of the below plus ▪ Provides creative strategic solutions for complex regulatory situations (domestic and global)

▪ Deep experience working with both US and international regulatory bodies, including

personal interfacing and negotiating with regulatory reviewers

▪ Partners with Clinical Affairs to structure and execute clinical studies in support of regulatory

submissions

▪ Conducts quality system audits and training programs

WFS-REG-ADV Regulatory Affairs

Advisor

▪ Provides guidance on, and prepares US and international regulatory submissions for new

products in development, as well as changes to existing products

▪ Offers council on requirements for human clinical trials to support US and international

regulatory submissions

▪ Provides guidance on the establishment and maintenance of quality systems that are

in compliance with FDA Quality System Regulation, ISO 13485, MDD and other international

standards



Clinical Affairs

WFS-CLIN Clinical

Specialist

▪ Collaborate with researchers to develop objectives for research, including the design, methods

and measures for quality control

▪ Replicate experiments and review statistical results for accuracy, validity and reliability

▪ Assist in the creation of written reports and presentations of the results to internal customers

▪ Monitor development and updates of the project on an ongoing basis

Validation Engineering

WFS-VAL-PRF

Principal Fellow

Validation

Engineer



WFS-VAL-PRN

Principal

Validation

Engineer

All of the below plus ▪ Develops and oversees validation policies and procedures, and insures they are in compliance

with corporate, QSR, ISO, and other RA compliance requirements

▪ Responsible for developing and implementing validation policy and site plans

WFS-VAL-SNR Senior Validation

Engineer

All of the below plus ▪ Interfaces with Quality and Manufacturing Engineers to review processes, determine

validation requirements and coordinate validation activities

▪ Works with suppliers, management, Engineers, and Manufacturing Associates in the resolution

of quality problems associated with the validation program

WFS-VAL Validation

Engineer

▪ Prepares and executes validation protocols and analyzes and documents validation test results

▪ Prepares compliance reports

▪ Makes adjustments or improvements to equipment and processes

▪ Keeps up-to-date on industry standards and regulations

Quality Assurance Engineering

WFS-QAE-PRF

Principal Fellow

Quality

Assurance

Engineer


▪ Advanced degree, additional credentials or fellowship experience in specific technical

area

WFS-QAE-PRN

Principal Quality

Assurance

Engineer

All of the below plus ▪ Maintains systems and procedures and champions implementation of new systems and

continuous improvement of systems and procedures to maintain ISO 13485 Certification ▪ Prepares the Market Spec and Product Spec, Review Drawings, manufacturing and testing

procedures

WFS-QAE-SNR

Senior Quality

Assurance

Engineer

All of the below plus ▪ Reviews requirements, specifications and technical design documents to provide timely and

meaningful feedback

▪ Prepares and maintains product risk management documentation (FMEA, risk management

plan and report, etc.)

▪ Confirms DV/V testing and determines all Market Spec and Product Spec requirements for

appropriate sample sizes based on risk analysis

▪ Represents QA in design reviews of new and redesigned products

▪ Assists with and sometimes leads quality system maintenance activities such as internal

auditing, CAPA, NCR, etc.

WFS-QAE

Quality

Assurance

Engineer

▪ Develops and applies testing processes (in line, lot release, RI, etc., as needed) for new and

existing products to meet client needs

▪ Tracks product and system QA metrics, such as defect rates, NCR closure times, etc.

▪ Investigates causes of non-conformance and trains users to implement solutions

▪ Assists with quality system maintenance activities such as internal auditing, CAPA, NCR, etc.

▪ Reviews manufacturing documentation and records for accuracy and compliance with

requirements



Quality Assurance Technicians

WFS-QAT-PRN

Principal Quality

Assurance

Technician

All of the below plus ▪ Monitors product quality

▪ Performs failure and routine analysis ▪ Reviews manufacturing documentation and records for accuracy and compliance with

requirements.

WFS-QAT-SNR

Senior Quality

Assurance

Technician

▪ All of the below plus ▪ Maintains gauges and testers

▪ Checks for regulatory compliance

▪ Assists with quality system maintenance activities such as internal auditing, CAPA, NCR,

etc.

WFS-QAT-TEC

Quality

Assurance

Technician

▪ Assures that all measuring instruments used are within calibration limits

▪ Conduct routine maintenance activities per approved schedules and non-routine

maintenance as requested

▪ Conducts manufacturing quality activity such as testing and inspection according to

specified requirements

▪ Prepares manufacturing quality documentation and records accurately and in compliance

with requirements

Marketing

WFS-VPM VP Marketing

▪ Develop annual marketing and service plan in support of organizational strategy and

objectives

▪ Ensure marketing communications are coordinated, support marketing plan objectives and

meet organizational expenditure requirements in conjunction with VP of Sales

▪ Oversee and direct market research, competitor analyses and customer service and retention

monitoring processes and initiatives

▪ Manage marketing services department, including development and distribution of all

marketing collateral

WFS-GPD Group Product

Director

▪ Research and development (R&D) of both new and existing products

▪ Determining marketing and sales strategy for products

▪ Owns the full responsibility of the strategy, success and failure for each product he or she

represents

▪ Spend a considerable amount of time engaging customers and educating them about the

product

WFS-PMA

Principal Product

Marketing

Analyst

▪ Utilizes secondary research resources to assess product markets and provide insights

regarding size, trends and dynamics

▪ Conducts primary market research to gather unpublished client insights

▪ Compares competitive products regarding technical and clinical differences and formulates

positioning and value proposition recommendations

▪ Makes assumptions and estimates new product sales projections

WFS-MGR-SPRD Senior Product

Manager

▪ Developing product requirements and roadmaps

▪ Leading product managers and coordinating with engineering, marketing and other teams

▪ Incorporating feedback and input from customers, partners and in-house teams on product

strategy and finding ways to expand product market reach

WFS-MGR-PRD Product Manager

▪ Determines customer needs and desires by specifying the research needed to obtain market

information

▪ Assesses market competition by comparing the company's product to competitors' products;

learning and communicating current and future market dynamics to internal stake holders

to capture market share

▪ Prepares sales forecasts for current and pipeline products

▪ Manages inventory turnover and product availability by reviewing and adjusting inventory

levels and production schedules



Sales

WFS-MGR-WWS Worldwide Sales

Manager

All of the below plus ▪ Coordinates the operations of the global sales discipline by establishing country-specific

goals, and monitoring sales volumes achieved by the various geographies

▪ Understands distribution channel, sales potential, customer needs and competitive pricing

requirements by country

WFS-MGR-NTS National Sales

Manager

All of the below plus ▪ Formulates and implements direct sales strategies, and leads national sales team to achieve

overall corporate sales goal

▪ Provides leadership through effective communication of vision, active coaching and

development while comparing sales results to goals and taking appropriate action to course

correct when necessary

▪ Determines sales management expectations, budgetary controls, compensation plans and

incentive programs. Manages team to meet / exceed monthly, quarterly and annual sales

forecasts

WFS-MGR-RGS Regional Sales

Manager

All of the below plus ▪ Responsible for directing the activities of a number of sales managers, each with their own

territory, which when combined comprise the region

▪ Organizes territories and executes on administrative responsibilities to ensure a high level of

customer satisfaction

▪ Coaches and mentors Sales Managers on effective selling techniques to ensure success

within individual territories

WFS-MGR-SLS Sales Manager

▪ Creates annual sales revenue plan by driving account and product strategies among client

targets within a specific territory

▪ Stays informed of new products, services and other general information of interest on behalf

of customers

Operations

WFS-OPSC Operations

Specialist

▪ Tracks and analyzes operational performance reports, including metrics

▪ Aligns business operations with customer needs to ensue satisfaction

▪ Serves as liaison between all departments to achieve a cohesive end result

WFS-VPO VP Operations

▪ Forms and executes strategic plans to enhance profitability, productivity and efficiency

throughout company operations

▪ Develops and directs management of the IT department

▪ Negotiates with vendors to ensure product relevance and cost effectiveness

WFS-OPSM Operations

Manager

▪ Analyzes and recommends part- and full-time employee mix for facility; coordinates

scheduling and real-time utilization of resources

▪ Keeps immediate superior promptly and fully formed of all potential problems or unusual

matters of significance, and takes prompt corrective action where necessary or suggests

alternative courses of action which may be taken

▪ Enacts contingency plans as needed; escalates and directs activities during systems problems, disasters, etc.

WFS-MAC Machinist

▪ Performs machine shop operations to support the assembly floor

▪ Performs prescribed preventative maintenance on machines as required, and detects and

reports defective materials or questionable conditions to supervisor

▪ Able to perform tasks including, but not limited to milling, turning, drilling, taping, de-

burring, molding, bench operations, etc.

WFS-LNLD Line Lead

All of the below plus ▪ Reads and interprets drawings or blueprints to assemble and then inspects product prior to

assembly, and troubleshoots equipment problems

▪ Completes time reporting forms and other related paperwork including, but not limited to

manufacturing forms, work order documents, stock movement tickets, scrap tickets,

identification tags, etc.

▪ Trains other operators as the subject matter expert for the work center

WFS-OPR Operator

▪ Works on lathe or similar machines and equipment

▪ Ensures production activities are in line with established quality standards, and that various

environmental health and safety regulations are adhered to

▪ Meets production deadlines and deliverables



Scientific

WFS-BIOM Biomaterials

Specialist

▪ Focuses on understanding the fundamental material science properties of product materials

and how these properties can add value in medical device applications

▪ Identifies new opportunities for use of new and novel materials in medical device

applications

WFS-TOXI Toxicologist

▪ Designs, plans and conducts controlled experiments, trials and field studies

▪ Performs risk assessments to determine the likelihood of harmful effects

▪ Collaborates and shares expertise and research findings with team members

WFS-STAT Statistician

▪ Designs data acquisition trials, assesses results and analyzes trends

▪ Applies statistical methodologies to complex data sets

▪ Uses statistics to formulate forecasts and projections

WFS-STER-MICR

Sterilization

Advisor /

Microbiologist

▪ Prepares validation plans, protocols and reports supporting sterilization testing and

validation activities for new and existing products

▪ Prepares plans, protocols and reports supporting biocompatibility testing and evaluation

activities for new and existing products

WFS-STER Sterilization

Advisor

▪ Prepares validation plans, protocols and reports supporting sterilization testing and

validation activities for new and existing products

WFS-MICR Microbiologist ▪ Prepares plans, protocols and reports supporting biocompatibility testing and evaluation

activities for new and existing products

WFS-FEA Fatigue Analysis

Specialist

▪ Evaluates current components, assembly, tooling, processes, and results previously

conducted by team members

▪ Establishes initial design, assembly and process parameters and procedures

▪ Conducts experiments to optimize design, assembly, tooling and processes

▪ Generates sketches, summaries, budgets and schedules for top solutions

Back Office & Other Support

WFS-WFM Workforce

Manager

▪ Recruits, hires, maintains, and terminates Associates as needed to support organizational

needs

▪ Maintains management guidelines by preparing, updating, and recommending workforce

management policies, procedures, and improvements

▪ Ensures that company policies and procedures reflect guidelines, and supports training to

encourage compliance

▪ Helps Associates understand how their contributions fit within the overall goals of the company

WFS-AOM Assistant Officer

Manager

▪ Ensures that office is open and operational upon Associate arrival, and also that office is

closed and locked at the end of the day –including maintenance of routine office supply

needs and the overall working environment.

▪ As requested, provides support to various departments including Workforce Management,

Accounting, Marketing, Project Management and Operations

WFS-ADM Administrative

Assistant

▪ Manages Reception Area, with applicable tasks including telephones, entry and exit, mail

and couriers

▪ Assists with purchasing for company using established Purchase Order system

▪ Facilitates meeting preparation and execution logistics

WFS-DCA

Document Control

Administrator

▪ Processes all change orders for procedures, drawings, specifications, GOPs, etc., through the

organization’s Change Control Process

▪ Distributes and tracks Engineering Changes (ECs), quality system related documents, and

production documentation as needed

▪ Maintains up-to-date electronic documentation files, department databases, and training

records

WFS-ACCT-SNR Senior Accountant All of the below plus ▪ Develops and maintains all financial reporting

▪ Analyzes sales and expense budget performance and prepares reports

WFS-ACCT Accountant

▪ Processes payroll, purchase orders and expense reports accurately and promptly

▪ Responsible for billing activities, including accounts payable and receivable

▪ Performs general bookkeeping, as well as administrative duties such as maintaining

schedules, providing telephone support, filing, transcription and the production of forms

▪ Provides financial data and analysis to project leaders and more senior Associates as needed



Business & Legal

WFS-ATY-IP Patent Attorney

▪ Discuss inventions and processes with inventors or manufacturers and ascertain whether

they're likely to succeed in being granted patents

▪ Write detailed descriptions of inventions in precise legal terms (patent drafts)

▪ Instruct on whether business activities will infringe someone else's patent rights

▪ Keep up to date with legal developments in the intellectual property field

▪ Advise on other intellectual property rights, e.g. designs or trade marks

WFS-RMB Reimbursement

Specialist

▪ Advises project leaders and more senior associates on how to ensure reimbursement,

including coding, coverage, and payment –facilitates process to ensure reimbursement

WFS-ATY-COR Corporate

Attorney

▪ Councils management on general contracts, third-party agreements, vendor supplier

relationships, and other relevant legal matters

▪ Brings and pursues lawsuits, including drafting / arguing pre-trial motions, conducting

depositions, participating in trial, and handling appeals

▪ Ensures company compliance with trademarks, patents, intellectual property and trade

secrets

▪ Often provides business counsel to senior staff

▪ Often advises on securities-related issues as needed

WFS-ATY-WF Workforce

Attorney

▪ Protects the rights of workers and defends company interests

▪ Works in a variety of settings, including private offices, courthouses and corporate

boardrooms

WFS-AGT-IP

Patent

Agent/Strategic

Manager

▪ Develops patent procedures for inventions and products

▪ Manages outside counsel with regard to patent applications and issues

▪ Educates senior management, inventors and process engineers on patent systems and

procedures

▪ Ensures compliance of local, state and federal laws relating to patent issues

▪ Advises on crafting coherent and strategic patent portfolio for the organization

WFS-IT IT Specialist

▪ Coordinates all operational aspects regarding company IT requirements

▪ Provides leadership in planning and managing computer related services and production

support, systems and database administration, network operations and desktop support

▪ Identifies and implements continuous IT improvement programs


SYSTEMS ACCESS & USE SERVICES1


SYST-AUA-INI Phase A

SYST A&U

First Project

See Systems Access & Use Table

SYST-AUA-INI-

SUS

Phase A

SYST A&U

First Project,

Suspended

This offering provides access to the same systems as in SYST-AUA-INI

Note: Suspended projects utilize fewer NMDDO resources2

than active projects.

SYST-AUA-SUB Phase A

SYST A&U

Subsequent Project


Note: The price for this offering is equal to SYST-AUA-INI as requirements for initial

and subsequent projects are similar in Phase A.

SYST-AUA-

SUB-SUS

Phase A

SYST A&U

Subsequent Project,

Suspended




SYST-AUI-INI Phase I-T

SYST A&U

First Project

See Systems Access & Use Table

SYST-AUI-INI-

SUS

Phase I-T

SYST A&U

First Project,

Suspended

This offering provides access to the same systems as SYST-AUI-INI



SYST-AUI-SUB Phase I-T

SYST A&U

Subsequent Project


Note: The price for this offering is lower than SYST-AUI-INI as annual requirements

for each company for SYST A&U are addressed through the initial project including the

client’s ISO 13485 quality system certification.

SYST-AUI-SUB-

SUS

Phase I-T

SYST A&U

Subsequent Project,

Suspended




1 Subject to availability from time to time and reasonable use as determined by NMDDO. 2 The following NMDDO Systems activities continue during Phase A project suspension: maintenance of all Quality and Business systems accessible per SYST-AUA-INI; training for Business systems accessible per SYST-AUA-INI; maintenance of the Client’s System and Controlled documents folders; maintenance and update (as needed) of the Client’s PO log, Forms, and SIG document. 3 The following NMDDO Systems activities continue during Phase I-T project suspension: maintenance of all Quality and Business systems accessible per SYST-AUI-INI; annual internal auditing of all Quality systems and Business systems; annual management review of Quality systems; annual implementation of Quality system objectives; maintenance of external standards; maintenance of contracts with key suppliers (e.g. Authorized representative); external audit by Notified body; training for Business systems accessible per SYST-AUI-INI; maintenance of Client’s System and Controlled documents folders; maintenance and update (as needed) of the Client’s company Quality system documents (e.g. PO log, Forms, SIG document, ORG chart, Quality Manual).

NOTE: In the event utilization of SYST A&U is for a period of less than one month, a per diem SYST A&U fee will be charged. The per diem fee is calculated by increasing the

monthly fee by 20%, and dividing the total by 20 business days.


ASSETS ACCESSIBLE WITH SYSTEMS ACCESS & USE

Catalog Code Systems Accessible with Systems Access & Use Agreement

SYST-AUA-INI

Quality

▪ Associate Conduct

▪ Control of Monitoring and Measuring Devices

▪ Documentation control

▪ General Safety Practices


software for POs

▪ Tooling Control

▪ Safety and Health Policy

Business

▪ Accounting Procedures

▪ Asset Review and Disposition

▪ Associate Lifecycle Management

Including Access to HR Management

software

▪ Business Systems Training

▪ Company Profile Management

▪ Company Travel Policy

▪ IT Services - Cloud Server Policy

▪ IT Services - Double Robot

▪ IT Services - General

▪ IT Services - Server Backup Policy

▪ Legal Activities

▪ Project Lifecycle Management

▪ Receiving of Visitors

SYST-AUI-INI

Quality

All of the above plus ▪ Canadian Medical Device Licensing

▪ Canadian Medical Device Problem Reporting

▪ Complaint Handling

▪ Control of Nonconforming product

▪ Corrective and Preventive action

▪ Design and Development

▪ Equipment, Process and Product Validation

▪ Identification and Traceability

▪ Internal audit

▪ Management Review

▪ Market Studies and Clinical trials

▪ Measurement Analysis and Improvement

▪ Medical Device Reporting

▪ Medical Device Vigilance System

▪ Monitoring and Measurement of Product

▪ Natural Disaster Plan

▪ Pest Control

▪ Production and Service Provision


software for Material Management and Sales Orders

▪ Record control

▪ Risk Management

▪ Sales Contract Review and Sales Order Initiation

▪ Sales Order Processing and Shipping

▪ Supplier Rating System

▪ Supplier Relations

▪ Technical Documentation

▪ Training

▪ Verification of purchased product

Business

All of the above plus • Documentation Standards

• Employee Performance Review

• Information Security

• Project Archiving Process

• Shipping Procedure


EQUIPMENT ACCESS & USE SERVICES1


EQMT-AUA-INI Phase A

EQMT A&U

First Project

See Equipment Access & Use Table

EQMT-AUA-INI-

SUS

Phase A

EQMT A&U

First Project, Suspended

This offering provides access to the same assets as EQMT-AUA-INI



EQMT-AUA-SUB Phase A

EQMT A&U

Subsequent Project


Note: The price for this offering is equal to EQMT-AUA-INI as requirements

for initial and subsequent projects are similar in Phase A.

EQMT-AUA-SUB-

SUS

Phase A

EQMT A&U

Subsequent Project,

Suspended




EQMT-AUI-INI Phase I-T

EQMT A&U

First Project

See Equipment Access & Use Table

EQMT-AUI-INI-

SUS

Phase I-T

EQMT A&U

First Project, Suspended

This offering provides access to the same assets as EQMT-AUI-INI



EQMT-AUI-SUB Phase I-T

EQMT A&U

Subsequent Project


Note: The price for this offering is lower than EQMT-AUI-INI as annual

requirements for each company for EQMT A&U are addressed through the

initial project.

EQMT-AUI-SUB-

SUS

Phase I-T

EQMT A&U

Subsequent Project,

Suspended




1 Subject to availability from time to time and reasonable use as determined by NMDDO. 2 The following NMDDO Equipment-related activities continue during project suspension: equipment/asset maintenance (e.g. calibration, preventive maintenance, licensing fees) NOTE: In the event utilization of EQMT A&U is for a period of less than one month, a per diem EQMT A&U fee will be charged. The per diem fee is calculated

by increasing the monthly fee by 20%, and dividing the total by 20 business days.


ASSETS ACCESSIBLE WITH EQUIPMENT ACCESS & USE:

Catalog Code Assets Accessible with Equipment Access & Use Agreement

EQMT-AUA-INI

▪ 3D printer (Fuse Deposition

Modeling: ABS)

▪ 3D Printer (Multi jet Fusion:

Photocurable plastic resin)

▪ 3D Modeling software

(SolidWorks Professional 2012-

2017, PDM Vault)

▪ Acid Storage Cabinet

▪ Analog Dial Indicators

▪ Analog Micrometer

▪ Balances / Scales

▪ Chart recorders

▪ Compressor / Integrated Dryers

▪ Computers

▪ Conference Tables

▪ Cordless Drill

▪ Depth Micrometer

▪ Dial Indicator

▪ Digital Calipers

▪ Digital Micrometer

▪ Digital Microscopes

▪ Digital Microscope Camera

▪ Digital Thermometer

▪ Digital Vision System

▪ Diopters

▪ Edge Router

▪ External Hard Drive

▪ Eyepiece-less Stereo

Microscopes

▪ Force Gauges

▪ Force Gauge Fixtures

▪ Furnace (2000°F capability)

▪ Gauge Block Set

▪ Gauge Sets

▪ Glue Dispensers

▪ Heat Gun

▪ Heat Sealers

▪ Horizontal Tensile Testers

▪ Lab Scale

▪ Laser Cutter

▪ Laser Micrometers

▪ Load Cells

▪ Manometer

▪ Microcell Signal Extender

▪ Microfinish Comparator Set

▪ Mini-Lathe

▪ Mini-Mill

▪ Monitors

▪ Monitor Stand

▪ Multimeter

▪ Office Chairs

▪ Office Partition Panels

▪ Office Phones

▪ Oscilloscope

▪ Pin Gauges

▪ Pinch Gauge

▪ Precision Arbor Press

▪ Precision Sine Vise

▪ Printer

▪ Projectors

▪ Reflow Oven

▪ Router and Switch

▪ Rulers

▪ Server

▪ Socket Set

▪ Soldering Irons

▪ Stereo Microscopes

▪ Tape Measures

▪ Telepresence Robot

▪ Thread Gauges

▪ Timers

▪ Tool Boxes and Tools

▪ Tool Cabinets

▪ Torque Gauges

▪ UV Curing Lamps

▪ UV Wand

▪ Vein Model

▪ Vertical Tensile Testers

▪ Vises

▪ VPN License

▪ Wash Station

▪ Weight Set

▪ Wi-Fi

▪ Work Benches

▪ Work Station Tables

▪ Work Stools

EQMT-AUI-INI

All of the above plus

▪ Validated EtO Sterilization

Cycle

▪ Controlled Environment Rooms

▪ Mill

▪ Lathe

▪ Mill/Lathe Accessories

▪ Toolmakers Microscope

▪ Universal Tensile Tester

▪ 3D Measurement Device

▪ Air Sampler

▪ Air Velocity Meter

▪ Angle Block Set

▪ Auto Sealers

▪ Backup UPS’s

▪ Bandsaw

▪ Barcode Scanner

▪ Chop Saw

▪ Controlled Environment Room A/C

Units

▪ Digital Measurement Tool

▪ Digital Thermohygrometer

▪ Electro Surgical Generator

▪ Endoscope Light Source

▪ Processors

▪ Environmental Chamber

▪ Extension Jaw Calipers Freight Scale

▪ Granite Slab Table

▪ Height Gauge

▪ High Voltage Power Supply

▪ Hydraulic Dynamometer

▪ Ionizers

▪ Laser Light

▪ LED Light Meter

▪ LED Vacuum Oven

▪ Light Box

▪ Lockers

▪ Machine Shop Tables

▪ Machining Accessories

▪ Magnehelic Gauges

▪ Microscope Camera Adapter

▪ Microscope Light Source Particle

Counters

▪ Pocket Thermometer

▪ Product Label Printers

▪ Loupe Scale

▪ Sealer

▪ Syringe Pump

▪ Tappi Chart

▪ Temperature Controller

▪ Thermohygrometers

▪ Thermometer

▪ Ultrasonic Cleaners

▪ Vacuum Pump

▪ Variable Auto Transformer

▪ Water Heater


FACILITIES ACCESSIBLE WITH EQUIPMENT ACCESS & USE

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