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Core Competencies
Role fitCore Competencies
Use this summary to align your resume positioning with the role.
Demonstrates expertise in developing and managing product requirements, risk management, and design verification and validation within the medical device industry. Proficient in technical writing, analytical problem-solving, and cross-functional collaboration in fast-paced environments.
Highest-signal resume keywords
Medical Device Risk ManagementDesign Verification and ValidationRequirements TraceabilityHazard Analysis and FMEATechnical Writing
ATS Keywords
Tailor your resumeApplicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills
Requirements DevelopmentRisk EvaluationDesign ControlVerification and Validation PlansFMEA ActivitiesDesign History File ManagementTechnical Problem-SolvingRoot-Cause EvaluationTesting CoordinationRegulatory Compliance
Soft Skills
Analytical SkillsOrganizational SkillsCommunication SkillsCollaboration SkillsProblem-Solving Skills
Tools & Technologies
Requirements Management ToolsDocument Control ToolsProduct Lifecycle Management ToolsLaboratory Testing EquipmentDesign Control Software
Industry Keywords
Biomedical EngineeringMechanical EngineeringElectrical EngineeringSystems EngineeringClass III Medical DevicesISO 14971FDA RequirementsCardiovascular DevicesInterventional DevicesEmerging Medical Device Companies
About the role
Key responsibilities & impact- Develop, document, and maintain user, system, subsystem, and product requirements
- Translate clinical, user, business, and technical needs into clear, measurable, and testable design inputs
- Maintain bidirectional traceability among user needs, design inputs, risk controls, verification and validation activities, and design outputs
- Identify documentation gaps, conflicts, and dependencies and support DHF and project files during audits and regulatory reviews
- Support product risk-management activities throughout the development lifecycle
- Develop and maintain hazard analyses, design/use/process FMEAs, risk evaluations, risk-control measures, and risk traceability
- Facilitate cross-functional risk discussions and ensure risk controls are incorporated into requirements, design outputs, and verification activities
- Evaluate new information, design changes, and test results for impact on the risk management file
- Develop and maintain design verification and validation strategies, plans, protocols, test methods, acceptance criteria, and reports
- Coordinate and participate in laboratory, bench, and system-level testing
- Review test data and document technical conclusions
- Investigate test failures, anomalies, and unexpected results, including root-cause evaluation and follow-up documentation
- Collaborate with internal teams and external laboratories or vendors to plan and execute testing
- Support design-control activities from development planning through design transfer
- Help maintain an inspection-ready Design History File
- Communicate technical risks, dependencies, decisions, and testing status to project stakeholders
- Contribute to technical problem-solving, design reviews, development planning, and continuous improvement
- Own failure investigations, Health Hazard Evaluations, Nonconformance Reports, and Corrective and Preventive Actions
- Work cross-functionally with R&D, Quality, Clinical, Regulatory, and Manufacturing
Requirements
What you’ll need- Bachelor's degree in Biomedical Engineering, Mechanical Engineering, Electrical Engineering, Systems Engineering, or a related engineering discipline
- 3-5 years of systems engineering or closely related R&D experience within medical device product development
- Hands-on experience working within a medical device design-control environment
- Experience developing or managing product requirements and requirements traceability
- Experience supporting medical device risk management, including hazard analysis and FMEA activities
- Experience developing and executing design verification and/or validation plans, protocols, and reports
- Working knowledge of Design History File requirements and disciplined engineering documentation practices
- Strong technical writing, analytical, organizational, and problem-solving skills
- Ability to work effectively across technical disciplines and functions in a fast-paced, evolving development environment
- Experience developing Class III medical devices preferred
- Experience with cardiovascular, catheter-based, interventional, or other complex medical device systems preferred
- Experience in an early-stage or emerging medical device company preferred
- Familiarity with ISO 14971 and applicable FDA and international medical device design-control requirements preferred
- Experience with requirements-management, document-control, or product-lifecycle-management tools preferred
- Experience coordinating testing with external laboratories, suppliers, or development partners preferred
Benefits
Comp & perks- Bonus opportunities
- Equity
- Company-sponsored benefits
- Limited relocation assistance may be available for candidates willing to relocate
- Hybrid work with flexibility for remote work