Design Quality Engineer - Robot

The Opportunity:

As a Design Quality Engineer, you will provide design quality support for the company’s design control activities, with a primary focus on the development of the surgical robot. You will partner with the R&D, regulatory, and clinical development engineering teams to ensure that our cardiovascular robotic platform is designed for safety, reliability, and manufacturability.

What you’ll do:

• Support the execution of design control activities, ensuring compliance with ISO 13485 and FDA 21 CFR 820.30 throughout the Product Development Process.

• Support creation of Risk Management Files, including the development of Design FMEA and Use FMEA.

• Review and approve Design Verification and Validation protocols, test methods, and reports to ensure devices meet all functional, clinical, and standards-based requirements.

• Participate in design reviews, providing critical feedback on design controls and risk mitigation.

• Review and maintain Design History File documentation and ensure compliance to internal processes and external standards and regulations.

• Champion the quality system and identify continuous improvement opportunities

• Support internal and external audits, including preparation of documentation, participation in audits, and implementation of audit findings 

• Drive nonconforming material investigations and implementation of effective CAPAs

• Ensure compliance with relevant regulatory requirements, such as FDA QMSR and ISO 13485 standards.

What you’ll need:

• Bachelor's degree in Engineering or a related technical field. Master's degree is a plus.

• Minimum of 5 years of experience in a design quality assurance/engineering role within the medical device industry supporting electromechanical capital devices. 

• In-depth knowledge of design controls (21 CFR 820.30), risk management (ISO 14971), quality management systems (ISO 13485), basic safety and essential performance of medical electrical equipment (IEC 60601-1), and other relevant quality & safety standards for robotic medical devices.

• Ability to support multiple concurrent design control activities in a fast-paced startup environment

• Strong documentation, organizational, and communication skills.

Ways to stand out from the crowd:

• Experience supporting development of surgical robotic devices.

• Certifications such as Six Sigma and ASQ Certified Quality Engineer (CQE).

• Excellent problem-solving skills and ability to apply root cause analysis methodologies.

• Detail-oriented with effective organizational and documentation skills.

Why join us:

• We offer a fun, fast-paced, collaborative environment where you will be working on transformational technologies in the cardiac healthcare space.

• We offer outstanding benefits with medical, dental, and vision covered at 100% for you and your family, as well as flex time off. 

• We thrive in our work-hard, play-hard environment. Bring your bike or running shoes if you’d like or just be ready to enjoy a fun office outing. We enjoy time inside the office and out!