We are seeking a passionate Product Development Engineer to join our R&D team in Fairfield, NJ. This role will be integral to the design, development, and testing of new orthopedic implants and surgical instruments. You will collaborate closely with cross-functional teams to bring innovative orthopedic products from concept to market—ensuring performance, manufacturability, and compliance with global regulatory standards.
Key Responsibilities:
· Design and develop implants, instruments, and sterilization systems using SolidWorks 3D CAD and in accordance with company design control processes.
· Participate in cross-functional product development teams, contributing from concept through product launch.
· Create working prototypes and iterate designs based on feedback and testing outcomes.
· Develop and execute test protocols and perform design verification and validation activities.
· Generate and maintain Design History File (DHF) documentation in compliance with regulatory standards.
· Create and manage Engineering Change Orders (ECOs).
· Ensure all designs adhere to GD&T standards (ASME Y14.5-2018) and are optimized for manufacturability (DFM).
· Support regulatory submissions by preparing necessary technical documentation (FMEAs, V&V reports, etc.).
Qualifications:
· Bachelor's degree in Mechanical or Biomedical Engineering.
· 5 years of experience in product development of orthopedic implants, preferably in hip or knee joint systems.
· Proficient in 3D CAD modeling, preferably SolidWorks.
· Hands-on experience in phase-gate design control processes and documentation.
· Familiarity with manufacturing processes (machining, forging, casting) and working with external vendors.
· Strong understanding of anatomy as it pertains to orthopedic joints.
· Proficient in GD&T, DFM, and creating regulatory-compliant design documentation.
· Strong organizational, verbal, and written communication skills.
At b-ONE, you’ll have the opportunity to make a tangible impact in the medical device industry, working on life-changing products in a collaborative and forward-thinking environment.
Pay: $50.00 - $75.00 per hour
Work Location: In person
