Design Quality Engineer; Electromechancial

Job Title:
Design Quality Engineer (Electromechancial)

Location:
Newton,MA

Pay rate: $70/hr w2

Duration: 12 Months

Job Description/ Responsibilities:

• 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 (21 CFR 820.30), ISO 13485, 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 14971 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&V) planning, execution, and reporting.
• Review and approve V&V protocols and reports to ensure adequate coverage of requirements, risks, and regulatory expectations.
• Support electrical safety and EMC compliance testing, including IEC 60601-1, IEC 60601-1-2, and IEC 80601-2-77, 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&V documentation for IDE, De Novo, and/or PMA submissions.
• Sustaining Activities-
• 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.

Required/Preferred skills to have for the success of this role:

• Minimum 4-year degree in Engineering, Biomedical Engineering, or Life Sciences.
• 7 to 10 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-13485 and ISO-14971 is required.
• Experience supporting the development of compliant medical device software or SaMD (i.e, IEC 62304/82304) 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 and professional communication skills with both internal and external stakeholders.
• Effective written communication skills, with the ability to author clear, concise, and accurate procedures, analyses, protocols and reports.
• Effective time/task management skills; excel working in a fast-paced environment.