R&D Engineer

Roles & Responsibilities:

• Demonstrated experience working under Design Controls and ISO 13485 / FDA QSR environments.

• Proven ability to conduct root cause analysis and support field driven corrective actions.

• Strong written and verbal communication skills, including the ability to translate clinical feedback into engineering actions.

• Ability to work independently, prioritize multiple issues, and lead cross functional technical efforts.

• Direct exposure to field action support, complaints investigations, or post market surveillance.

• Familiarity with human factors standards (IEC 62366), risk management (ISO 14971), and related FDA guidance.

• Experience working closely with clinicians, clinical engineers, or medical affairs teams.

Education & Experience:

• Bachelor's degree in engineering or related technical field (mechanical, biomedical, or equivalent).

• 5 to 6 years of medical device development experience, including sustaining or post market engineering surveillance.

• Experience with structural heart or transcatheter cardiovascular devices.

• Experience owning or supporting IFUs, user needs, or human factors engineering for Class III medical devices.