Job Title: Product Development Design Engineer
Job Number: 23265
Location: Boston, MA
The candidate will take a lead role in the design, development and validation of a medical device from concept through market introduction. Design and develop medical instruments (disposable and reusable), sterilization and packaging, from concept through market introduction. Ensure that designs meet performance specifications, regulatory and manufacturing requirements. 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. The candidate will interact closely with the surgeons and the product development team to develop new products and modify existing products to fulfill customer needs. Review competitive IP landscape for the company’s current product portfolio and future technology plans, protecting Company’s IP. Oversee, manage, and coach the in-house team working on IP generation. Draft IP Disclosures and Interact with the companies external IP counsel.
- Medical device product design and development experience is required.
- Experience in robotics preferred, not required
- Ability to work in a fast-paced startup environment
- Concept to prototype to commercial product experience strongly preferred
- Demonstrated ability to bring products from concept to market.
- SolidWorks 3D CAD proficiency.
- Familiarity with FDA QSR and ISO 13485 medical device regulations.
- Depth of knowledge in one or more product areas; Robotic Surgery is desired.