Quality Engineer, Software Design Controls

📋 Description

• Own software design control strategy across implantable electronics software, surgical robotics
• Collaborate with software/firmware teams to identify design control risks early and drive
• Manage end-to-end software design control activities across the full lifecycle for regulated
• Develop and maintain design control deliverables: plans, requirements specs, architecture docs
• Improve compliance processes, SOPs, templates, and knowledge sharing across teams.

🎯 Requirements

• Bachelor’s degree in Computer Science, Software Engineering, Biomedical Engineering, or related
• 3+ years of hands-on experience with software design controls, software quality, or software design
• Strong understanding of SDLC in regulated or safety-critical environments and practical application
• Experience planning, executing, reviewing, and documenting software design control and
• Working knowledge of IEC 62304, ISO 14971, and ISO 13485.
• Excellent cross-functional communication to drive issues to closure across engineering, quality

🎁 Benefits

• Opportunities to work with experts from diverse fields and contribute to world-changing medical
• Growth potential and rapid advancement for high-impact contributors.
• Comprehensive medical, dental, and vision insurance (PPO).
• Paid holidays, commuter benefits, meals provided.
• Equity (RSUs) for full-time employees (temporary employees/interns excluded).
• 401(k) plan (interns may have initial exclusions).