Product Development Engineer
MicroAire Surgical Instruments
The Product Development Engineer works within a project team to support the development of products from concept to viability. This individual will work with Product Innovation Management to research clinical applications and will be a technical voice that will derive product requirements from clinical and market research for assigned scope. The Product Development Engineer will then develop these product requirements into tangible products for the company that solve real clinical problems. The Product Development Engineer requires comprehensive mechanical and technical problem-solving skills.
- Contributes to derivation of product requirements from user needs that emerge from clinical and market research.
- Contributes to product design for assigned scope during concept phases through to design transfer during development with consideration for user needs, safety, reliability, manufacturability and ergonomics.
- Owns assigned design control documentation for products throughout development including requirements traceability, product risk management, product specifications and change documentation.
- Assists Product Innovation Management to support user evaluations including Usability and Design Validations.
- Assists Design Verification group to design test methods that will verify design inputs and analysis of test results to ensure design inputs were met.
- Assists Manufacturing Engineering to satisfy Design Transfer elements including Manufacturing Process Instructions and Inspection Criteria.
- Participates in Voice of Customer and other clinical and market research with Product Innovation Management.
- This will include customer and other user interaction, surgery observation, and travel when necessary.
- Works with outside resources throughout development including part vendors, prototype shops, material suppliers, customers and other subject matter experts.
- Collaborates with internal resources including Project Management, Quality, Regulatory, Product Innovation Management and Testing to drive completion of product development and research activity.
- Performs other duties as needed.
Experience and Qualifications
Education Requirements: B.S. or M.S. in Mechanical Engineering.
Experience Requirements: 1-3 years Engineering Experience. Medical Device Experience a plus.
Job Knowledge, Skills, and Ability:
- Proficiency in 2D drafting and 3D modeling, preferably SolidWorks.
- Knowledge of ANSI Y14.5 drafting standards.
- Basic understanding of design of mechanical components and assemblies.
- Basic understanding of properties of various materials, such as stainless steel, aluminum, other common metals and polymers in the medical device industry.
- Basic understanding of part fabrication techniques, such as machining, injection molding, and finishing techniques.
- Basic understanding of factors that affect the life of reusabl surgical instruments, such as corrosion, wear and thermal cycling.
- Basic understanding of part tolerancing and tolerance stack-up analysis.
- Basic understanding of mechanical stress analysis.
- Good verbal and written communication skills.
- Good interpersonal and organization skills.
- Proficiency in Microsoft Office, Project and other job associated software.
- Ability to apply scientific reasoning and to develop test methodologies to resolve complex technical problems.
- Devices & Instrumentation