Design Quality Engineer

Roles & Responsibilities

• Act as a Quality subject matter expert supporting the development of sterile, single-use medical devices, with ownership of packaging, sterile barrier systems, sterilization, and biocompatibility considerations to ensure compliance with applicable standards and internal quality system requirements.
• Support risk management activities in accordance with ISO , including identification, analysis, mitigation, and documentation of risks throughout the design lifecycle within the Risk Management File.
• Support the development of Use, Design, and Process FMEAs to systematically identify and address potential failure modes and ensure appropriate risk controls are implemented.
• Support design verification and validation activities, including development, review, and approval of test plans, protocols, and reports, with a focus on compliance testing for biocompatible, sterile, single-use consumable products (, ISO , IEC -, packaging and sterilization-related testing).
• Support the development and maintenance of the Usability Engineering File in accordance with IEC and applicable regulatory requirements.
• Support supplier qualification and process validation activities, including review of supplier documentation and quality outputs.
• Support test and inspection equipment evaluation, method development, and qualification activities as required.
• Support manufacturing transfer activities, including creation and review of DMR/DHR documentation and execution or review of validation protocols (IQ, OQ, PQ).
• Develop, review, and maintain work instructions, manufacturing procedures, and inspection documentation to ensure alignment with validated processes and design requirements.
• Support the collection, analysis, and trending of quality and performance metrics to identify opportunities for improvement.
• Propose, lead, and support Corrective and Preventive Actions (CAPAs) to address systemic issues and ensure effective resolution.
• Lead and/or participate in product complaint investigations, including root cause analysis and documentation of findings.
• Support the disposition of nonconforming material, including collaboration with cross-functional teams to determine appropriate actions.
• Support other quality-related activities as assigned.

• Serve as the Quality representative and Design Controls lead on cross-functional teams developing complex electromechanical and robotic medical systems.
• Own and support Design Control activities across the product lifecycle in accordance with FDA QSR ( CFR , ISO , and applicable regulations.
• Support definition and approval of system- and subsystem-level design inputs that are clear, testable, and aligned to intended use and risk.
• Maintain end-to-end traceability between design inputs, outputs, risk controls, verification, and validation.
• Support design reviews, phase gate readiness, and Design History File (DHF) completeness.
• Lead and support risk management activities per ISO using a system-level, top-down and bottom-up approach.
• Ensure risk controls are implemented and verified, and residual risk is supported by objective evidence.
• Support tolerance, worst-case, and margin analyses as inputs to risk assessment and verification planning.
• Provide Quality oversight of design verification and validation (V&A) planning, execution, and reporting.
• Review and approve V&A protocols and reports to ensure adequate coverage of requirements, risks, and regulatory expectations.
• Support electrical safety and EMC compliance testing, including IEC -, IEC --, and IEC --, as applicable.
• Collaborate with Software Quality and Systems Engineering to ensure HW/SW integration risks are addressed.
• Support supplier qualification and design transfer for design-critical components and interfaces.
• Support preparation and review of Design Control, risk, and V&A documentation for IDE, De Novo, and/or PMA submissions.
• Supporting the collection and analysis of performance metrics.
• Proposing and leading Corrective and Preventive Actions (CAPAs).
• Leading and/or participating in product complaint investigations leading to root cause.
• Assisting in the dispositioning of non-conforming material.
• Supporting other duties as assigned by manager.

• Minimum
  -year degree in Engineering, Biomedical Engineering, or Life Sciences.
• to years of experience as a Quality or Design Quality Engineer in the medical device industry supporting the development of complex electro-mechanical Class III devices is required.
• Working knowledge of QSR, MDD/MDR, ISO- and ISO- is required.
• Experience supporting the development of compliant medical device software or SaMD (, IEC /) and SWFMEA development is required.
• Experience in applied statistics including use of Minitab or other statistical analysis software is required.
• Experience in CAPA, NCMR, complaint investigations is required.
• Familiarity with electrical component handling and ESD controls is required.
• Experience with supporting De Novo/PMA submissions is preferred.
• Effective…