Senior Software Design Quality Assurance Engineer

The Senior Software Quality Engineer works as part of the core product team to collaboratively drive the software development activities for embedded firmware and lead the risk management assessment and Quality deliverables. The candidate must possess an understanding of the software development life cycle processes as applied within the regulated medical device industry and be familiar with IEC 62304, 13485, 14971, and FDA QMSR. You will work with the core R&D team to drive quality into product development, including collaborating with Regulatory, R&D, Marketing, Medical Safety, and post-market Quality, and implement strategies that enable continuous improvement. Candidates must have strong verbal and written English communication skills with an ability to summarize complex technical details and risk information and be comfortable presenting data to a core team., * Bachelor’s Degree in Engineering, Science, or Technical field with 4 years of work experience in Quality, Engineering, and/or Software Development OR Advanced Degree in Engineering, Science, or Technical field with 2 years of work experience in Quality, Engineering, and/or Software Development.

• Experience supporting embedded firmware development in a Quality capacity in the medical device industry.
• Experience and familiarity with IEC 62304, 13485, 14971, and FDA QMSR.
• Experience driving quality compliance with design controls, risk management, and change control processes, and engaging as a Quality core team member with cross-functional team members.
• Experience leading product risk management activities including SW FMEA and system hazard analysis.