Senior Design Quality Engineer

Ampcus Inc. is a certified global provider of a broad range of Technology and Business consulting services. We are in search of a highly motivated candidate to join our talented Team.

Job Title: Senior Design Quality Engineer

Location(s): Newton, MA

Job Description
We are currently looking for an ambitious Senior Design Quality Engineer (contractor) to join our Endovascular Robotics business within Advanced Therapies. We are a global technology leader in robotic-assisted vascular interventions. We believe the combination of endovascular robotics, image guidance and dedicated devices will change the way neurovascular procedures will be done in the future, enabling better outcomes, and enabling our customers to provide better access to care.

• 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.

• 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 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.

Ampcus is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, age, protected veterans or individuals with disabilities.