MUST HAVE:
- Combination product exp (infusion pumps)
- DHF and Risk management file expertise
- End to End product development (systems engineering)
- work onsite in Chicago
We are looking for a highly motivated Design Quality Engineer to support the development and lifecycle management of combination products (drug-device, drug delivery, infusion pumps 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
- Elec