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Core Competencies
Role fitCore Competencies
Use this summary to align your resume positioning with the role.
Demonstrates expertise in system architecture development, requirements management, and technical documentation for medical device systems. Proficient in cross-disciplinary collaboration, risk management, and compliance with FDA, ISO, and QSR standards.
Highest-signal resume keywords
System Architecture DevelopmentRequirements ManagementTechnical DocumentationFDA ComplianceRisk Management
ATS Keywords
Tailor your resumeApplicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills
System-Level DesignIntegrationVerificationRoot Cause InvestigationChange ManagementStatistical ConceptsElectro-Mechanical SystemsTest MethodsVerification and ValidationTechnical Analyses
Soft Skills
Effective CommunicationMentorship
Industry Keywords
Medical Device DevelopmentDesign ControlsQSR RequirementsISO StandardsDevelopment PlansTraceability MatricesTest PlansFailure InvestigationsDesign TransferMulti-Disciplinary Collaboration
About the role
Key responsibilities & impact- Define, develop, and refine system architectures for new products and significant product enhancements
- Translate user, customer, and business needs into clear, testable system and subsystem requirements
- Support requirements flow-down to mechanical, electrical, and software teams
- Execute system development activities across concept development, requirements definition, design, verification and validation, and design transfer to manufacturing
- Develop, review, and maintain system-level documentation, including development plans, architectures, requirements, traceability matrices, specifications, test plans, protocols, reports, and technical analyses
- Provide technical guidance and informal mentorship to engineers and technicians
- Coordinate across disciplines and contribute to technical direction
- Support system-level testing, failure investigations, and technical assessments
- Evaluate reliability, manufacturability, serviceability, and risk throughout development
- Interface with suppliers, external partners, and test laboratories
- Support design reviews, testing execution, issue resolution, and design transfer readiness
Requirements
What you’ll need- Bachelor’s degree in Engineering or a related technical discipline, or an equivalent combination of education and experience
- Minimum 10+ years of progressively responsible engineering experience in product and/or systems development
- Exposure to system-level design, integration, or verification activities
- Ability to contribute to complex, multi-disciplinary system development efforts with defined objectives and moderate oversight
- Working knowledge of FDA, ISO, and QSR requirements applicable to medical device development and design controls
- Experience supporting electro-mechanical system architectures and managing requirements through verification and validation
- Proficiency in root cause investigation, risk management, change management, and technical documentation
- Effective written and verbal communication skills
- Working knowledge of engineering test methods and basic project management principles, including statistical concepts used in development and verification
- Ability to travel domestically and internationally up to approximately 20% as required
Benefits
Comp & perks- Equal opportunity employer
- Reasonable accommodations for applicants with disabilities
- Limitless learning and growth opportunities