Design Quality Engineer III - Bolt Integration
Core
Ensures safety, quality, and compliance of launched medical devices (specifically SEISMIQ console) through design controls, risk management, and end-of-life sustainment.
Role type
Senior Design Quality Engineer (Medical Devices)
Builds
Medical device products (SEISMIQ console) for commercial use
Domain
Medical Devices / Healthcare
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Design Control process, Risk Management (Hazard Analysis, FMEA, Fault Tree), CAPA ownership, Verification & Validation, Usability testing, Design History File management, System design impact assessment
Preferred skills
Cross-functional partnership, Problem-solving methodologies, Regulatory compliance knowledge
Technologies
Design Control tools, Risk Management software, FMEA tools
Responsibilities
Lead or support quality disciplines and practices; Investigate and implement best-in-class Design Quality Engineering practices; Participate in Design Change process and Design Control assessments; Partner with R&D and manufacturing to implement Design Controls based on risk and customer needs; Resolve quality issues including CAPA ownership; Monitor field performance of medical devices against risk assessments; Participate in Risk Change assessment and maintain risk management tools; Support verification, validation, and usability testing; Interact with software changes for system design impact; Develop and maintain Design History File and design input/output documentation
Seniority
Senior, hands-on IC