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:
- 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.
...Avenue, Bloomingdales, Holt Renfrew & Blue Mercury, as well as online, spas and owned retail. The brand retails over $100M annually and... ...looking for a talented and experienced Freelance Hair Stylist to join our team. As a freelance Hair Stylist at the Maison Sisley...
...The Engagement and Events Coordinator is responsible for planning, organizing, and executing company travel arrangements and company events. The Engagement and Events Coordinator embodies the characteristics of servant leadership, integrity, and customer-centric mindset...
NANNY / FAMILY ASSISTANT Seeking a warm, reliable, and organized Nanny/Family Assistant to provide attentive childcare and manage daily home operations for a busy family with several children. Parents are described by other staff as extremely nice and easy to work for...
...Solar Energy Solutions (SES) is seeking dedicated and skilled Solar Installers to join our team with a strong background in Mechanical. As a leading provider of solar energy... ...you! Responsibilities Install solar panels and associated components on residential rooftops...
...Research Technician I (Microscopy, Image Analysis, and Immunoblotting... ...scientific tasks and experiments under supervision. This entry... ...development through both pre-clinical and clinical trial-level experiments... ...log files and documentation associated with image analysis...