Key Responsibilities:
• Support product development activities across the full product lifecycle
• Manage product requirements, traceability, risk management, verification, and validation
• Create and maintain Design History File (DHF) documentation
• Perform impact assessments for design, process, and material changes
• Drive system-level problem solving, risk mitigation, and design realization
• Collaborate with cross-functional teams including Quality, Manufacturing, Regulatory, and R&D
Preferred Qualifications:
• BS/MS in Electrical, Mechanical, Biomedical, Software Engineering, or related discipline
• 3+ years of engineering experience
• Medical device experience preferred (ICU, kidney care, infusion, dialysis, etc.)
• Experience with V&V, system integration, testing, and design controls
• Knowledge of FDA, ISO, IEC regulated environments
• Experience with requirements management and traceability tools
• Familiarity with DOORS, Teamcenter, JIRA, ALM, TrackWise8, SysML, or UML is a plus
• Experience with connected devices, software-enabled products, or cybersecurity is preferred
Candidates from medical devices, aerospace, automotive, defense, or other regulated product development environments are encouraged to apply.
If interested, please send your updated resume along with:
• Current Location
• Work Authorization
• Availability
• Expected Rate