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Core Competencies
Role fitCore Competencies
Use this summary to align your resume positioning with the role.
Demonstrates expertise in systems engineering and product design for embedded, electro-mechanical medical devices, with a strong focus on regulatory compliance and risk management. Proficient in defining system requirements, architecture, and verification strategies while collaborating across cross-functional teams.
Highest-signal resume keywords
Systems EngineeringEmbedded Systems DevelopmentRegulatory Compliance (FDA, ISO)Risk Management (DFMEA, Hazard Analysis)Cross-Functional Collaboration
ATS Keywords
Tailor your resumeApplicant Tracking System Keywords
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Hard Skills
Systems EngineeringEmbedded Systems (C, C++)Verification and ValidationDesign Requirements ManagementTechnical Documentation ReviewData Flow ManagementArchitecture DesignUsability TestingGMP Certified Manufacturing ProcessesISO 14971 Compliance
Tools & Technologies
IoT CommunicationCybersecurity Risk Management
Industry Keywords
Medical Device DevelopmentRegulated EnvironmentUL/IEC StandardsFDA 510(k)PMAEU MDR
Tech Stack
Tools & technologiesCyber SecurityIoTC++
About the role
Key responsibilities & impact- Advise cross-functional teams on new product development as the technical bridge across Mechanical, Electrical, Software, Quality, and V&V teams
- Define and manage system requirements, architecture, interfaces, and data flows while ensuring end-to-end requirements traceability
- Lead technical planning, system design, and architecture reviews
- Evaluate alternatives based on performance, cost, risk, and supportability
- Support risk management activities, including Hazard Analysis, DFMEA, usability, and ISO 14971 requirements
- Collaborate with V&V teams to develop and execute verification and validation strategies against design inputs and intended use
- Review technical documentation supporting product development and global regulatory submissions, including FDA 510(k), PMA, and EU MDR
- Participate in assigned reasonable work activities
- Conform to, support, and enforce company policies and procedures
- Travel up to 10% domestic/international may be required
Requirements
What you’ll need- Bachelor’s degree or higher in engineering from an accredited institution and minimum of seven (7) years combined industry experience in systems engineering and/or product design in a regulated environment, OR High School Diploma/GED and eleven (11) years combined industry experience in systems engineering and/or product design in a regulated environment
- Five (5) years’ experience in design, development, and testing of embedded, electro-mechanical medical devices
- Five (5) years’ experience in a regulated design environment with medical device development and FDA or ISO registered work experience
- Five (5) years’ experience in GMP certified Manufacturing Processes and UL/IEC Standards
- Two (2) years of hands-on experience in Systems Engineering with products including C or C++ embedded systems, IoT Communication, and/or Cybersecurity risk management
- Must be legally authorized to work in the country of employment without sponsorship for employment visa status
Benefits
Comp & perks- Medical, Dental & Vision
- Health Savings Accounts
- Health Care & Dependent Care Flexible Spending Accounts
- Disability Benefits
- Life Insurance
- Voluntary Benefits
- Paid Absences
- Retirement Benefits
- Relocation Assistance may be authorized
- Hybrid work arrangement with some remote work