Performance Engineer

3 weeks ago

Fairfield Essex County NJ, United States b-ONE Ortho, Corp. Full time

We are seeking a passionate Product Development Engineer to join our R&D team in Fairfield, New Jersey. This role will be crucial in designing, developing, and testing 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. Initially, your responsibilities will include developing specialty instruments for Surgeon customers.
Key Responsibilities:

- Design and develop implants, instruments, and sterilization systems using SolidWorks 3D CAD and adhering to 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 (COs).
- 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:

- Bachelors 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.

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