- Posted by Dextera MIS
- On November 17, 2016
Staff R&D Engineer
This position provides technical expertise to the design and development of new & existing minimally invasive surgical device product(s). This position also has primary responsibility for later stage development aspects of new product development. Is a member of a multi discipline product development team executing rapid design cycles and delivery of products meeting cost, quality, and schedule commitments.
- Designs and implements new methodologies, materials, machines, processes or products.
- Will contribute to cross-functional development teams through product design, research investigations, preparation of specifications, verification and validation testing, process development, and design control documentation.
- Conduct feasibility studies of the design to determine ability to function as intended.
- Creates prototypes from design concepts.
- Turns concepts into fully functional products.
- Performs troubleshooting on new products/process problems as related to design, material, or process.
- Maintains detailed documentation throughout all phases of research and development.
- May coordinates activities with outside suppliers and consultants to ensure the delivery of supplies or services needed to meet scheduled timelines.
- Provide support in the resolution of product complaints and/or product issues.
- Perform job functions in accordance with applicable GMP and ISO standards.
- Needs the following MFG process experience: stamping, plastic injection molding, machining, heat treating, & chem etching. MIM’s, Swiss Screw Machining, & coatings experience a plus.
- Must have basic understanding of stats, mechanical systems, material properties, gamma sterilization, mfg. fixture design, protocols/reports. In-depth knowledge/experience in stats, pkg engineering, IFU/labeling, biocompatibility testing, COGS analysis desired and considered a plus.
- Thorough knowledge of principles, technologies and materials employed in the design, manufacture and testing of medical interconnects plastics and stamping.
- Proficiency in 3D modeling, Advanced used of Solid works, or other statistical software, FEA software (CAD, SolidWorks), project management, and office software. Minitab, Autodesk, FEA &/or LabVIEW highly desired and considered a plus. Experience in tolerance stack ups and FEA analysis.
- Excellent interpersonal, collaborative, & problem-solving skills.
- Strong oral and written communication.
- Proficient with MS Excel, Word, PowerPoint, and MS Project
- Bachelor’s degree in Engineering (preferably BS Mechanical Engineering), or related technical degree.
- Eight (8+) years’ of experience, (R&D) environment, or M.S. degree and six (6) years’ of experience.
- Experience in mechanical surgical device product development required
- Demonstrated track record of developing MIS products from inception to 510k approval process and commercial release.
- Proven success in the development of products from inception to prototype production, FDA approval to manufacturing transfer & ongoing development engineering & manufacturing support.