DePuy Synthes Companies of Johnson & Johnson is the largest, most innovative and comprehensive orthopaedic and neurological business in the world. DePuy Synthes Companies will offer an unparalleled breadth and depth of products, services and programs in the areas of joint reconstruction, trauma, spine, sports medicine, neurological, craniomaxillofacial, power tools and biomaterials. Building on the legacy and strengths of two great companies, we are creating one organization that will be agile and better equipped in today's evolving health care environment. With a focus on activating insights to develop innovative, comprehensive solutions, we are inspired to advance patient care in greater ways than either company could accomplish on its own.
Codman Neuro is the Neurological business focused on neurosurgery (CNS), neurovascular (CNV) and neuromodulation, offering a broad portfolio of solutions including programmable shunt systems, catheters, trauma monitoring devices, drug pumps, neurovascular coils, liquid embolics and vascular reconstruction devices.
The Quality Engineer 2 will be responsible Codman Neuro NPD CNS projects of varying scope and complexity. The Quality Engineer 2 will interact with external design and development partners, participating on cross-functional project team through all phases of the product development process, and assisting the technical team with planning, executing, documenting and communicating testing activities. The Quality Engineer 2 may also be responsible for the electrical and hardware aspects of a project.
• Lead and/or support the design and development of medical device in close collaboration with R&D.
• Lead and/or support risk analysis activities (FMEAs and SHAs).
• Support external partners in the development of product.
• Coordinate, review and approve development documentation created by external partners, including product requirements, schematics, code, verification and validation test strategy, protocols and reports.
• Support Design Reviews, Technical Reviews, and Peer Reviews.
• Fulfill design control requirements compliant; examples: software specifications, detailed design files, design verification and validation test plans, risk management, DHF, protocols, and reports in accordance with company procedures, FDA and ISO guidelines.
• Collaborate with internal and external partners to launch new products.
• Participate to internal and external audits.
• Maintain the Quality System.
• A minimum of a Bachelor’s degree in Engineering along with a minimum of 3 years in a regulated industry - Required
• A degree in Electrical, software, or Mechanical Engineering - Required
• Experience in medical device product development including Design Verification & Validation – Preferred
• Experience with Electrical safety testing (i.e., 60601-1) - Preferred
• Experience with Software development life cycle (i.e., 62304) - Preferred
• Demonstrated detailed design analysis, statistical analysis and mathematical analysis for a robust and manufactural device – Preferred
• Demonstrated leadership abilities
• Strong analytical skills
• Knowledge of QSR: FDA 21 CFR 820 and ISO 13485 requirements - Preferred
• Knowledge of international Standards: ISO 9000, ISO 13485, ISO 14971, IEC 62304, IEC 60601 - Preferred.
• This position is based in Raynham, MA and requires up to 10% domestic travel.