Shaping the Future of Orthopedics
At b-ONE, we are committed to transforming orthopedic care through advanced technology, improved healthcare economics, and a passion for restoring patients’ active lifestyles. Our mission is to enhance the experience of both patients and surgeons by delivering innovative solutions in implant design, robotics, artificial intelligence, advanced manufacturing, and material science.
With a relentless focus on innovation and value, we strive to deliver best-in-class orthopedic solutions that not only meet clinical needs but also contribute meaningfully to global healthcare systems. Our ultimate goal is to help more people worldwide regain their mobility and quality of life—through the most advanced tools humankind has ever created: innovative technology.
Role: Product Development Engineer
Location: On-site – Fairfield, NJ
Employment Type: Full-Time
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.
- 1–5 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.
Job Type: Full-time
Pay: $120,000.00 - $140,000.00 per year
Benefits:
- Dental insurance
- Health insurance
- Paid time off
Work Location: In person
