Senior Quality Engineer, Product Software Development

at  Johnson Johnson

DePuy Synthes, part of Johnson & Johnson Family of Companies is recruiting a Senior Quality Engineer, Product Software Development to be located in Boston, MA, Raynham, MA or Palm Beach Gardens, FL.
At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at https://www.jnj.com/.
The Senior Quality Engineer, Product Software Development, will provide quality oversight for new product project teams responsible for the development of medical device software systems. The Senior Quality Engineer 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 team delivering outstanding results to our customers? Apply now for this exciting opportunity!

EDUCATION:

• A minimum of a Bachelor’s Degree is required. An Advanced Degree is preferred. Focus degree in Engineering, Computer Science, Information Systems, Biomedical/Bio-engineering Degree are preferred.

• Support the design, development and testing 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.
• 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.
• Provide technical support for audits of software suppliers and software consultants.
• Conduct training on Medical Device Software development processes and quality systems.
• Provide expertise in applicable industry standards and regulations including, but not limited to as IEC 62304, FDA guidance, FDA Part 11, ISO13485, EU MDR, ISO14971, IEC 62366.