Design Quality Engineer (medical devices)

We are looking for a highly motivated Design Quality Engineer to support the development and lifecycle management of combination products (drug-device and/or biologic-device), including electromechanical medical devices and connected systems. This role is responsible for ensuring product quality and regulatory compliance throughout the design and development process, with a strong emphasis on risk management, design controls, electrical/mechanical system compliance, and cross-functional collaboration. The ideal candidate brings deep expertise in medical device quality engineering within a regulated environment and has experience working on complex combination products and electromechanical medical devices from early development through commercialization. Key Responsibilities Design Quality & Development Support Provide quality engineering support for design and development activities in accordance with applicable regulatory requirements and standards (e.g., FDA 21 CFR Part 820, ISO 13485, IEC 60601 series). Ensure compliance with design control requirements, including design planning, inputs/outputs, verification, validation, and design transfer. Support development of electromechanical medical devices, including electrical, mechanical, software, and system-level interfaces. Review and approve design documentation to ensure completeness, accuracy, traceability, and regulatory alignment. Ensure appropriate application of safety and performance standards for electrical medical equipment, including IEC 60601-1 and related collateral/particular standards. Risk Management Lead and facilitate risk management activities in accordance with

ISO 14971.

Develop and maintain risk management files, including hazard analyses, DFMEAs/PFMEAs, use-related risk analyses, and risk-benefit assessments. Evaluate electrical, mechanical, software, usability, and system-level hazards associated with electromechanical and combination products. Ensure risks are appropriately identified, mitigated, verified, and documented throughout the product lifecycle. Combination Product & Regulatory Compliance Support compliance with combination product regulations, including 21 CFR Part 4. Collaborate with regulatory and development teams to ensure alignment between device and drug/biologic requirements. Provide guidance on quality expectations for device constituent parts, electromechanical subsystems, and integrated delivery systems. Support compliance activities related to

IEC 60601, IEC

62366, and other applicable medical device safety and usability standards. Design Verification & Validation (V&V) Review and approve verification and validation protocols and reports. Ensure test methods are scientifically sound, traceable to requirements, and properly documented. Support electrical safety, EMC, environmental, reliability, software, and system integration testing for electromechanical devices. Support execution and troubleshooting of V&V activities as needed, including

IEC 60601

compliance testing and third-party lab coordination. Change Control & Lifecycle Management Assess and approve design changes for impact on product quality, safety, performance, and regulatory compliance. Participate in change control boards and ensure proper documentation and justification of changes. Support post-market activities, including complaint investigations, CAPA, and field actions related to design and system-level issues. Evaluate impact of hardware, firmware, software, and component changes on product safety and compliance. Cross-Functional Collaboration Work closely with R&D, systems engineering, manufacturing, regulatory affairs, software engineering, and suppliers to ensure quality is embedded throughout the product lifecycle. Provide quality input during design reviews, system architecture discussions, and technical risk assessments. Support supplier qualification and component quality for electrical, mechanical, and electromechanical device constituents. Audit & Inspection Readiness Support internal and external audits, including regulatory inspections and notified body audits. Ensure design history files (DHFs), risk management files, and technical documentation are inspection-ready. Address audit findings and implement corrective actions as required. Required Qualifications Bachelor's degree in Engineering (Mechanical, Biomedical, Electrical, Systems Engineering, or related discipline). Minimum 5+ years of experience in quality engineering within the medical device or combination product industry.

Strong knowledge of:

FDA 21 CFR

Part 820 and Part 4 ISO 13485 and

ISO 14971 IEC 60601

series standards for medical electrical equipment Design controls and risk management processes Electromechanical medical device development and lifecycle management Experience supporting combination products, connected medical devices, or drug-device integration. Proven experience with design verification and validation activities, including electrical safety and EMC testing. Strong analytical, problem-solving, and technical writing skills. Preferred Qualifications Advanced degree (MS or equivalent) in a relevant engineering field. Experience with injection devices, auto-injectors, infusion systems, wearable devices, or other electromechanical delivery systems.

Familiarity with:

IEC 62366

(Usability Engineering)

IEC 62304

(Medical Device Software Lifecycle) EMC and electrical safety testing requirements Certification such as ASQ Certified Quality Engineer (CQE) or similar. Experience working in a cross-functional, global development environment. Experience supporting regulatory submissions involving electromechanical or connected medical devices.

Pay:

$45.00 - $70.00 per hour

Work Location:

In person