Staff Quality Engineer, Product Software Development

DePuy Synthes Companies, a member of Johnson & Johnson's Family of Companies, is recruiting for a Staff Quality Engineer, Product Software!

The DePuy Synthes Companies are part of the Johnson & Johnson Family of Companies. We offer one of the world’s most comprehensive portfolios of orthopedic products and services in the areas of joint reconstruction, trauma, spine, sports medicine, cranio-maxillofacial, power tools and biomaterials. With a focus on activating insights to develop innovative, comprehensive solutions, we are inspired to advance patient care and keep people moving!

The Staff Quality Engineer, Product Software, will provide quality leadership on new product project teams responsible for the development of medical device software systems. As a Staff Quality Engineer you will be the subject matter expert in requirements gathering, facilitating software risk assessments, defining test strategies, and guiding project teams on design controls and defect analysis.

Are you interested in joining a diverse and dynamic team that is helping improve patient care and drive innovation? Apply today!

Key Responsibilities:

• Support the design, development, testing and maintenance of Medical Device Software, including Software as a Medical Device (SaMD) products
• Provide leadership, guidance and expertise on the software development process, procedures and practices. Enhance processes to reflect state of the art practices and drive continuous improvement
• Partner with R&D to refine requirements, and to ensure that architecture/ design documents are comprehensive
• Facilitate the documentation and tracking of verification activities, including code review findings
• Review test case execution results and manage defects
• Facilitate software risk assessment sessions and own the development of risk documents
• Support regulatory filings and registrations
• Support internal and external audits or inspections of SaMD products and processes and own Non-conformances or CAPAs and drive root cause investigations
• Train and mentor new engineers and lower-level quality engineers
• Provide expertise in applicable industry standards and regulations including, but not limited to IEC 62304, FDA QSR and Guidance, FDA Part 11, ISO13485, EU MDR, ISO14971, and IEC 62366-1
• Provide technical support for audits of software suppliers
• Know, understand, incorporate and follow all applicable laws and regulations relating to Depuy Synthes business activities and Policies and Procedures of the Health Care Compliance Program and Code of Conduct.