Sage Product Development, Inc.

Position Description
Position Title:

Product Development Engineer

Date: 7 November 2014

Reports To:

President

FLSA exempt

COMPANY OVERVIEW:
Sage Product Development, Inc. provides fast, efficient and creative product development services
to medical device companies. We are a focused team of experienced medical device engineers
who know what it takes to develop successful products for startups, multinational companies, and
everyone in between.
We combine a high level of experience with a low overhead company structure. We are all about
solving client companies technical challenges and meeting their product development needs in a
timely, efficient and highly personalized manner.
We offer the right candidate the opportunity to work in an entrepreneurial environment, enhance
their product development engineering abilities, and build their network within the industry.
GENERAL SUMMARY:

Develop medical devices from concept through market introduction on a contract basis for client
companies.

Meet or exceed customer expectations.

ESSENTIAL JOB FUNCTIONS (all as required by client companies):

Design and develop medical devices (disposable and reusable), catheters, equipment, implants,
and/or packaging, from concept through market introduction. Ensure that designs meet
performance specifications, regulatory and manufacturing requirements.

Interact with client companies in a professional manner. Proactively communicate with client
companies to ensure an ongoing two-way exchange of information.

Generate innovative concepts for new medical device designs to satisfy customer and clinical
requirements. Lead and participate in concept generation activities, including brainstorming
sessions. Refine, rate, rank and/or otherwise assess concepts.

Utilize SolidWorks to develop detailed 3-D CAD models and drawings, including component,
subassembly, and top-level drawings.

Investigate and evaluate existing technology for application to projects.

Design and implement new methodologies, materials, machines, processes or products as

required to achieve product development goals.

Produce prototype devices for testing and evaluation. Work with internal and/or external resources
to produce prototype device components. Assemble and/or evaluate prototype devices.

Conduct bench and/or animal feasibility studies.

Conduct product verification and validation testing to demonstrate product safety and efficacy.
Determine what testing is required to satisfy product requirements, to investigate potential failure
modes, and to otherwise address the project design inputs. Develop protocols, plan testing, and
perform or monitor testing. Utilize statistical methods as required to plan testing and to analyze test
results. Write test reports which draw conclusions from the results.

Conduct risk analyses. Conduct and document Failure Mode and Effects Analyses.

Perform tolerance analysis of components and assemblies to ensure proper fit and functionality.

Coordinate activities with outside suppliers and consultants to ensure the delivery of supplies or
services needed to meet customer expectations.

Maintain detailed essential product and process documentation throughout all phases of research
and development. Maintain Design History Files (DHFs). Ensure that DHFs are accurate, complete
and well organized.

Prepare documentation release packages, including detail drawings, bills of material, and/or
procedures. Approve Document Change Orders (DCOs) and obtain approvals from others as
required.

Ensure that all work satisfies the requirements of client companies Quality Systems, with particular
emphasis on Design Control.

Conduct and document Design Reviews.

Participate in Material Review Board activities. Make decisions regarding product and material
discrepancies and initiate appropriate action to prevent subsequent problems or discrepancies.

Date, sign and have witnessed all documents that may establish inventorship dates.

Significant local travel (i.e. by car). Occasional long-distance travel (i.e. by plane).

OTHER DUTIES AND RESPONSIBILITIES

Any other duties as assigned.

REQUIRED COMPETENCIES
Customer Focus

Provide professional, reliable and prompt service to client companies and coworkers. Work in
partnership with others to meet or exceed customer expectations. Interpret customers needs and
take appropriate action. Follow through on customers inquiries in a professional and timely
manner.

Management of Resources

Work in an organized and time effective manner. Proactively seek out relevant reference materials
as necessary. Take initiative for self-development. Prioritize tasks effectively. Demonstrate initiative
and innovation in the use of available resources.

Communication Skills

Write and speak in a concise, technically accurate, timely, and professional manner. Exhibit strong
verbal presentation and negotiation skills. Interact with client company personnel in a positive and
professional manner. Express ideas, recommendations and solutions clearly, logically and
concisely in both written and verbal communications. Demonstrate tact and diplomacy in
communications. Demonstrate active listening skills and ability to resolve discrepancies with
customers.

PREPARATION, KNOWLEDGE, SKILLS & ABILITIES:

Bachelor's degree in Mechanical or Biomedical Engineering is required. Masters degree in

engineering, management or business is a plus.

Some prior medical device product design and development experience is required.

Demonstrated ability to bring products from concept to market.

Ability to interact with client companies in a professional manner.

SolidWorks 3D CAD proficiency is required.

Knowledge of probability and statistics.

Flexibility, persistence, resourcefulness, a drive to succeed, and an entrepreneurial spirit.

SUPERVISORY RESPONSIBILITY:

May direct the work of other people, and may have direct reports.

WORKING CONDITIONS/PHYSICAL DEMANDS:

Must be able to move throughout office and laboratory space, using a complete variety of office
equipment and laboratory machinery and tools. Must be able to lift more than 50 pounds and stand
for extended periods of time. Must tolerate exposure to chemicals found in a laboratory
environment.

The above statements are intended to describe the general nature and level of work being
performed by people assigned to do this job. The above is not intended to be an exhaustive list of
all responsibilities and duties required.

External and internal applicants, as well as position incumbents who become disabled as defined
under the Americans with Disabilities Act must be able to perform the essential job functions (as
listed) either unaided or with the assistance of a reasonable accommodation to be determined by
management on a case by case basis.

CONTACT:

Please reply to jcerier@sagepd.com