Senior experience leading quality for complex hardware and software products in a regulated environment.
Deep familiarity with design controls, design history file (DHF), document control, risk management, and verification planning.
Strong systems thinking with an ability to translate ambiguous product intents into testable requirements.
Comfortable collaborating directly with multidisciplinary teams including reconnaissance/machine learning, embedded systems, mechanical engineering, electrical engineering, and cloud computing.
Experience with eQMS and document control systems that integrate with engineering workflows.
Responsibilities
Own and evolve the Quality Management System (QMS) to support regulated medical device development, focusing on design controls and DHF maintenance.
Establish and enforce requirements traceability, linking user needs to design requirements and verification/validation artifacts.
Define and execute the program-level verification and validation (V&V) strategy, including creation of test plans and acceptance criteria.
Drive risk management activities, ensuring mitigations are reflected in requirements and verification through DFMEA and PFMEA processes.
Lead document control processes including reviews, approvals, training, and audit readiness preparation.
Integrate quality practices within the development workflow, collaborating with engineering on automated testing and release gates.
Prepare the program for audits and inspections, providing leadership during audits.
Benefits
Opportunities for professional development and growth within a regulated environment.
Collaborative work culture with a diverse team of multidisciplinary engineers.
Involvement in transformative projects at the intersection of hardware and software.
Full Job Description
What you'll do
Own and evolve the Quality Management System (QMS) to support a regulated medical device development program, including design controls and DHF maintenance.
Establish and enforce requirements traceability: user needs 12 design requirements 12 verification/validation artifacts and change control.
Define and run the program-level V&V strategy (verification, validation, and test coverage), including test plans, protocols, reports, and acceptance criteria.
Drive risk management activities (e.g., DFMEA / PFMEA, hazard analyses) and ensure mitigations are reflected in requirements and verification.
Lead document control: reviews, approvals, training, retention, and audit readiness.
Partner with engineering to make quality "native" to the dev workflow (automated testing, release gates, software configuration management).
Prepare the program for audits and inspections, including hands-on audit leadership.
What we're looking for
Senior experience leading quality for complex hardware + software products in a regulated environment.
Deep familiarity with design controls, DHF, document control, risk management, and verification planning.
Strong systems thinking and the ability to translate ambiguous product intent into testable requirements.
