Product Development Engineer

We are a fast-paced implantable medical device company currently transitioning from the clinical stage to commercialization. Mid-way through a pilot clinical study and actively preparing an FDA submission for market clearance, we are at a critical juncture and require a high-impact player to drive our technical operations.

We are seeking a highly driven Product Development Engineer with proven experience and expertise in technical developments for the medtech industry. Operating within a mature Quality Management System, this role demands an agile, systems-level thinker who thrives at the intersection of R&D, product development, mechatronics, and project management.

Responsibilities:

• R&D & Rapid Prototyping: Act as the technical lead to manage and participate in the design, prototyping, manufacturing, and testing of implantable medical devices. Transform user inputs and regulatory requirements into viable device designs, utilizing rapid prototyping tools to iterate quickly.

• Automation & Mechatronics: Design and assemble custom hardware and controllers (e.g., Arduino-based platforms). Integrate and control stepper motors, servos, and sensors to build custom bioreactors, test fixtures, and specialized R&D equipment.

• Test Engineering: Develop comprehensive testing methodologies from scratch. Execute the mechanical, physical, chemical, and biological testing of medical devices, ensuring robust data collection and analysis.

• Tooling & External Vendor Management: Design specialized tooling for both commercial manufacturing and the testing of medical devices. Source, evaluate, and direct external machining providers to manage the fabrication of these tools, acting as the primary technical liaison.

• Technical Project Management: Own the lifecycle of engineering projects. Accurately project costs, manage resources, and oversee external consultants. Lead multidisciplinary technical discussions with clinical, research, and production staff.

• Rigorous Documentation: Oversee the writing of standard operating procedures, product documentation, and ensure detailed oriented record keeping and technical documentation. Produce high-level engineering reports and technical memos that support regulatory submissions to federal agencies.