Senior Medical Device Systems Engineer (Hybrid)

Warwick Consulting Limited; Boston (MA); Hybrid; USD 120,000 - 180,000; Full time

Job summary

Warwick Consulting Limited is seeking a Senior Systems Engineer to drive systems engineering activities for medical device products, translating user needs into measurable design inputs and ensuring traceability throughout development. The role requires a strong DHF/design controls background and collaboration with Engineering, R&D, Quality, and Regulatory Affairs.

Ideal candidates will have 7+ years of experience, familiarity with Diagnostic Imaging systems, and the ability to coordinate across

Qualifications

• Bachelor’s degree in a technical discipline or equivalent experience.
• 7+ years in systems engineering, requirements, or design controls in medical devices.
• Strong ability to assess requirements quality for clarity, completeness, traceability, and testability.
• Experience building or maintaining system architecture and interfaces across multidisciplinary teams.
• DHF and design control experience including documentation review and remediation.

Responsibilities

• Elicit, clarify, document, and maintain user needs and system requirements for medical device capital equipment.
• Develop, document, and maintain system architecture, boundaries, interfaces, and design relationships.
• Coordinate with hardware, software, electrical, mechanical, imaging, and other engineering disciplines for cohesive system design.
• Maintain end-to-end traceability from user needs to verification evidence and DHF documentation.
• Support design reviews, milestones, audits, and remediation activities with cross-functional teams.

Skills

Design controls

Traceability

Systems engineering

Regulatory alignment

Cross-functional collaboration

Requirement management

Education

Bachelor’s degree in Systems or Biomedical/Electrical/Mechanical Engineering

Tools

PLM

Requirements management tools

Job description

Warwick Consulting Limited is seeking a Senior Systems Engineer to drive systems engineering activities for medical device products, translating user needs into measurable design inputs and ensuring traceability throughout development. The role requires a strong DHF/design controls background and collaboration with Engineering, R&D, Quality, and Regulatory Affairs.

Ideal candidates will have 7+ years of experience, familiarity with Diagnostic Imaging systems, and the ability to coordinate across