Build and own design controls for HW and SW.
Establish ISO 13485 §7.3 design templates and DHF structures.
Define scalable DHF/design evidence model for distributed dev.
Design-change impact assessment within QMS change control.
Drive ISO 14971 risk mgmt integration with hazard analysis and FMEAs.
Author and review verification/validation protocols and design transfer readiness.

🎯 Requirements

3+ years in medical devices with design controls, V&V, and risk mgmt.
Proven track record building design control frameworks across distributed teams.
Expertise ISO 13485, FDA 21 CFR 820, ISO 14971, IEC 62304.
Ability to lead cross-functional design reviews and audit-ready DHFs/RMFs.
Excellent technical writing; translate requirements into templates and checklists.
20% domestic travel.

🎁 Benefits

Healthcare, dental, mental health support
Parental planning resources
Retirement savings options
Generous paid time off
Inclusive, accessible workplace with accommodations

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