Design Quality Co-Op
Found in: beBee jobs US - 1 week ago
DePuy Synthes provides one of the most comprehensive orthopedics portfolios in the world. DePuy Synthes Digital Orthopedics is focused on revolutionizing the digital landscape of surgery with a focus on Robotic Assisted Surgeries, Augmented Reality, and other novel technologies. For more information, visit .
In line with our dedication to our CREDO J&J offers excellent employee benefits including excellent health care, family leave, and retirement planning. A co-op experience at J&J counts as full time service if a future permanent hire is made towards these benefits.
Our growing team uses technology to improve the performance, accuracy, and safety of a wide range of surgical procedures.
You will support product quality, engineering, and reliability, ensuring the implementation and sustained support of groundbreaking technology for medical devices and digital health solutions is safe, effective, and follows regulations, standards, and industry practices. Working closely with multi-functional teams you will act as a domain specialist for mechanical / electronic hardware throughout the development lifecycle. You will review and assess product development results (e.g. user needs, design & development plans, requirements, design documentation, risk management file, and verification & validation artifacts) to ensure that they align with applicable procedures standards and regulatory requirements.
Our growing team uses technology to improve the performance, accuracy, and safety of a wide range of surgical procedures.
Key Responsibilities:
- Learn and engage on the product development process
- Provide input for verification and validation of digital health technologies
- Guide in establishing product and software requirements, specifications, detailed design, verification and validation protocols and planning documentation
- Review all project / program outputs (e.g. plans, requirements, specifications, test protocols, test cases, test results, traceability, risk management documents, reports)
- Potential to attend cadaver labs
- Collaborate and learn about DePuy Synthes procedures, global ISO standards (ISO 13485, ISO14971, IEC62304), regulations (e.g. 21 CFR Part 820, 21 CFR Part 11, European Union Medical Device Directive (MDD)/ Medical Device Regulation (MDR), and applicable guidance
- Participate in technical design reviews and project phase reviews
- Support internal audits and external audits by regulatory agencies, as required
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