Senior Design Quality Engineer

Our client, a global leader in healthcare technology, is seeking a Senior Design Quality Engineer (1-year contract) to join their team. As a Senior Design Quality Engineer, you will be part of the Endovascular Robotics business within Advanced Therapies, supporting cross‑functional teams in the development of innovative robotic‑assisted vascular interventions. The ideal candidate will have strong analytical skills, attention to detail, and effective communication, which will align successfully in the organization.

Senior Design Quality Engineer (1-year contract)

Newton, MA

$60 - $70/hour

• 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, ISO 13485, and applicable regulations.
• Maintain end‑to‑end traceability between design inputs, outputs, risk controls, verification, and validation.
• Provide Quality oversight of design verification and validation (V&V) planning, execution, and reporting.
• Support risk management activities and ensure compliance with system‑level and regulatory requirements.

• Minimum 4‑year degree in Engineering, Biomedical Engineering, or Life Sciences.
• 7–10 years of experience as a Quality or Design Quality Engineer in the medical device industry supporting complex Class III electro‑mechanical devices.
• Knowledge of QSR, MDD/MDR, ISO 13485, ISO 14971, and experience with medical device software standards (IEC 62304/82304).
• Experience in CAPA, NCMR, complaint investigations, and applied statistics using tools like Minitab.
• Effective communication and time/task management skills in fast‑paced environments.

• Work with a global team of 66,000 professionals dedicated to pioneering healthcare innovations.
• Exposure to advanced endovascular robotics and image‑guided therapy technologies.
• Opportunity for professional growth in a dynamic and inclusive environment.
• Flexible and challenging work environment allowing personal and professional development.
• Contribute to projects that directly impact patient outcomes and access to care worldwide.

• Medical and Prescription Drug Plans
• Dental Plan
• Vision Plan
• Health Savings Account
• Health Flexible Spending Account
• Dependent Care Flexible Spending Account
• Supplemental Life Insurance
• Short Term and Long Term Disability Insurance
• Business Travel Insurance
• 401(k), Plus Match
• Weekly Pay

If this is a role that interests you and you’d like to learn more, click apply now and a recruiter will be in touch with you to discuss this great opportunity. We look forward to speaking with you!