Systems Engineer, Verification & Validation (Hybrid - Acton, MA)
Core
Leading verification and validation activities for medical device new product development and sustaining products, ensuring compliance with regulatory standards and quality policies.
Role type
Senior Systems Engineer, Verification & Validation
Builds
Medical device products (insulin delivery systems, automated insulin delivery systems)
Domain
Medical Devices / Biomedical Engineering
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Systems Engineering, Verification & Validation planning, Requirements analysis, Test case development and execution, 3rd party testing management, Regulatory compliance (IEC/AAMI/UL 60601-1, ISO 13485, FDA Design Controls), Configuration management, Technical mentoring
Preferred skills
Leadership of cross-functional teams, System level testing of software-based medical devices, Project management under QMS, Innovative FDA-regulated device development
Technologies
DOORs, Helix, Jama, JIRA, Confluence, Bamboo
Responsibilities
Manage V&V activities and deliverables for NPD and sustaining products; Develop detailed V&V plans and schedules; Perform requirements analysis and manage test cases; Collaborate with Systems Engineering to ensure testable requirements; Create and document robust test methodologies; Conduct formal and informal communication with team members; Analyze design changes for regression testing; Provide technical consulting and mentoring; Manage 3rd party verification activities; Perform verification testing following test cases; Maintain product configuration management; Ensure compliance with quality policies and regulations.
Seniority
Senior, hands-on IC with leadership responsibilities