Biomedicine, Cardiovascular, Communication Skills, Corrective Action, Cross-Functional, Establish Priorities, FDA (Food and Drug Administration), Human Factors, ISO (International Organization for Standardization), International Electro-Technical Commission (IEC), Medical Affairs, Medical Equipment, On Site Support, Presentation/Verbal Skills, Quality System Requirements (QSR), Research & Development (R&D), Risk Management, Root Cause Analysis, Surveillance, Writing Skills
LOCATION
Santa Clara, CA
POSTED
30+ days ago
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.