About the position
MicroAire Surgical Instruments, a mid-sized medical device company in Charlottesville Virginia, is seeking a Staff Product Development Engineer. The Staff Product Development Engineer is a senior member of the technical team for Product Innovation. This individual works within a project team to develop products from concept into viable products. The Staff Engineer will be working on complex problems and will lead system or sub-system level development efforts. 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. The Staff Product Development Engineer will then develop these product requirements into tangible products for the company that solve real clinical problems. Requires comprehensive mechanical and technical problem-solving skills.
Responsibilities
- Promotes a high performing team within a culture of empowerment and accountability that delivers regular product introductions in alignment with innovation strategy.
- Leads team members by listening to, supporting, and promoting success of individuals and teams in the Innovation department.
- Acts as a technical expert providing strategic direction as well as hands on guidance and understanding for the team.
- Promotes and engages in cross functional collaboration to promote greater efficiency and effectiveness among project teams.
- Owns derivation of product requirements from user needs that emerge from clinical and market research.
- Owns new product design from concept to production during development with consideration for user needs, safety, reliability, manufacturability and ergonomics.
- Owns design control documentation for products throughout development including requirements traceability, product risk management, product specifications and change documentation.
- Leads system and sub-system level technical effort for development and design option evaluation.
- 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.
- Investigates new technology for application in product development.
- 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.
Requirements
- B.S. or M.S. in Mechanical Engineering, Biomedical, or other applicable technical disciplines.
- Minimum of 7 years Engineering Experience.
- Medical Device Experience a plus.
- Proficiency in 2D drafting and 3D modeling, preferably SolidWorks.
- Knowledge of ANSI Y14.5 drafting standards.
- Thorough understanding of CFR 820.30, ISO 14971, and IEC 62366.
- Thorough understanding of design of mechanical components and assemblies.
- Thorough understanding of properties of various materials, such as stainless steel, aluminum, other common metals and polymers in the medical device industry.
- Thorough understanding of part fabrication techniques, such as machining, injection molding, and finishing techniques.
- Thorough understanding of factors that affect the life of re-usable surgical instruments, such as corrosion, wear and thermal cycling.
- Thorough understanding of part tolerancing and tolerance stack-up analysis.
- Thorough 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.
Benefits
- Compensation mensurate with experience.
- 401K with company match.
- Medical/Dental/Vision.
- Vacation & Paid Holidays.
