Experience owning or supporting IFUs, user needs, or human factors engineering for Class III medical devices. Roles & Responsibilities: Demonstrated experience working under Design Controls and ISO 13485 / FDA QSR environments.
Numbers & Facts
Location
Houston, TX
Description
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.
Requirements:
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.