Bachelor's degree in engineering or related technical field (mechanical, biomedical, or equivalent)
5 to 6 years of medical device development experience
Experience with structural heart or transcatheter cardiovascular devices
Demonstrated experience in Design Controls and ISO 13485 / FDA QSR environments
Strong written and verbal communication skills
Ability to work independently and lead cross-functional teams
Familiarity with human factors standards (IEC 62366) and risk management (ISO 14971)
Responsibilities
Conduct root cause analysis and support corrective actions based on field data
Translate clinical feedback into actionable engineering solutions
Prioritize and manage multiple technical issues independently
Lead cross-functional efforts in technical problem solving
Support field action initiatives and complaint investigations
Engage with clinicians and clinical engineers to gather insights
Ensure compliance with relevant standards and guidelines in product development
Benefits
Opportunity to work in a cutting-edge medical device environment
Engagement with clinical professionals and multidisciplinary teams
Exposure to significant regulatory frameworks in the medical field
Participation in innovative projects related to cardiovascular health
Professional development in the area of human factors and risk management
Full Job 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.
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.
