Design Control Engineer

Ready to engineer precision in the surgical world? Join our client’s cutting-edge team and play a vital role in developing the instrumentation that powers tomorrow’s breakthroughs.

R&D Partners is seeking a meticulous and proactive Design Control Engineer to lead and manage design control activities across the product lifecycle. You will ensure that the robotic surgical systems meet regulatory requirements and quality standards from concept through commercialization. This role is critical to maintaining compliance, traceability, and documentation integrity in a fast-paced, innovation-driven environment.

Please note that to be considered for this role you must have the right to work in this location.

Responsibilities:

• Develop, implement, and maintain design control processes in accordance with FDA 21 CFR Part 820, ISO 13485, and other applicable standards
• Create and manage Design History Files (DHF), including design inputs, outputs, verification, validation, risk management, and change control
• Collaborate with R&D, Regulatory, and Quality teams to ensure alignment of design activities with product requirements and intended use
• Facilitate design reviews and ensure proper documentation of decisions and actions
• Support risk management activities (ISO 14971), including hazard analysis and FMEA
• Ensure traceability between user needs, design inputs/outputs, and test protocols/results
• Participate in audits, inspections, and regulatory submissions as the design control subject matter expert
• Drive continuous improvement of design control procedures and tools

Key Skills and Requirements:

• Bachelor’s or Master’s degree in Engineering, Quality, or related field
• Proven working experience in design control within the medical device industry
• Understanding of FDA QSR, ISO 13485, ISO 14971, and IEC 62366
• Experience with DHF documentation, risk management, and product development processes
• Excellent organizational, communication, and cross-functional collaboration skills
• Detail-oriented with a strong sense of ownership and accountability
• Familiarity with robotic systems or complex electromechanical devices
• Experience with eQMS platforms (e.g., MasterControl, Greenlight Guru)
• Knowledge of usability engineering and human factors

For more information, please contact Toby Shelton.

If you are interested in applying to this exciting opportunity, then please click ‘Apply’ or to speak to one of our specialists visit the ‘Contact Us’ page.

R&D Partners is a leading life sciences recruiter focused on finding exceptional people and matching them with the finest positions across the globe. R&D Partners is acting as an Employment Agency in relation to this vacancy.

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