Qualifications

• Bachelor's degree in engineering or a related field (mechanical, biomedical, or equivalent).
• 5-6 years of experience in medical device development, particularly in sustaining engineering or post-market surveillance.
• Direct experience with structural heart or transcatheter cardiovascular devices.
• Familiarity with Instruction for Use (IFUs), user needs, and human factors engineering for Class III medical devices.
• Knowledge of Design Controls, ISO 13485, and FDA QSR regulations.

Responsibilities

• Work within ISO 13485 and FDA QSR frameworks for compliance and quality.
• Conduct root cause analysis and implement corrective actions based on field feedback.
• Translate clinical feedback into actionable insights for engineering teams.
• Manage multiple projects independently while fostering cross-functional collaboration.
• Support field action initiatives, complaints investigations, and post-market surveillance.
• Adhere to human factors standards and risk management protocols.
• Collaborate closely with healthcare professionals and medical affairs teams.

Benefits

• Opportunity to work in a dynamic and innovative medical device environment.
• Exposure to cutting-edge technology in cardiovascular medical devices.
• Collaboration with cross-functional teams including clinicians and engineers.
• Potential for professional growth in an established yet evolving company.
• Engagement in meaningful projects that impact patient care.