About the role
Software Design Quality Assurance Staff Engineer role based on the published job description. Key responsibilities and requirements were extracted directly from the posting for quick review.
Life SciencesOnsite
Key Responsibilities
- Serve as Software Design Quality lead on multiple programs with significant business and regulatory impact.
- Contribute your Design Quality expertise to next generation NPI software and instrument systems.
- Coach, lead, and enable software teams to deliver products efficiently and in compliance with FDA and EU regulatory standards. Process Improvement
- Lead continuous process improvement initiatives for software product development in areas such as cybersecurity, AI adoption, risk management, pre- and post-market support, and change control.
- Contribute to an evolving training curriculum to enable and promote cultural adoption of design compliant SDLC activities.
- Study evolving global standards and perform gap assessments to incorporate process improvement opportunities. Project Execution
Requirements
- Minimum Qualifications
- BS in computer science, engineering, biology, or similar technical subject area.
- Direct experience in software product development activities from product concept to launch.
- 5-10 years of experience in FDA/EU regulated environments (ISO 13485).
- Understanding of design control activities for planning, design, development, verification, and validation of Software as a Medical Device (IEC 62304).
- Working knowledge of ISO 14971 and 21 CFR Part 11.