Design Quality Engineer III

Design and deliver the medical device and supplies breakthroughs that make a difference in the lives of millions of patients. Responsible for ensuring that software used in the development, manufacturing and as part of medical devices is developed according to good design practices and follows the corresponding requirements set forth by local procedures, regulatory authorities and notified bodies. Provide leadership, oversight and training to division manufacturing plants for computerized system validation.

Mentor design teams on quality systems and requirements.

• Working knowledge of the FDA Quality System Regulation, ISO 13485, and the Medical Device Directive
• Skilled in product risk assessment (ISO 14971), requirements management and tracing, defect tracking, configuration management techniques, and knowledge of how these are applied in the software development lifecycle
• Experience in Agile software development techniques and IEC 62304 requirements, versed in guidance documents such as TIR-45, IEC TR 80002-1 and Cyber security guidance from FDA
• Understanding of current Software Quality techniques, software industry standards (e.g. ISO, IEEE, CMMI), and FDA Quality System Regulations and their impact on internal procedures, software quality, safety and efficacy of products
• Experience in risk evaluation techniques, such as Product Risk Assessment and FMEA including software risk assessment and software FMEA
• Familiar with reliability analysis and test methods, including software reliability modeling
• Working knowledge of C and C++
• Good verbal (including presentation) and written communication skills
• Ability to effectively work on project teams.

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