DQA Manager
Core
Leads and oversees pre-commercialization design quality assurance efforts for new medical device products, focusing on software quality and performance verification.
Role type
Senior Design Quality Assurance Manager (Medical Devices)
Builds
Defibrillators and patient monitoring systems for EMS, hospital, and military customers
Domain
Medical device hardware and software (cardiopulmonary/respiratory)
Deliverable
production ML models | product features | infrastructure
Required skills
System level design verification and validation, risk management, usability principles, software development lifecycle management, test strategy development, audit and approval of QA procedures, stakeholder management with Project and Engineering teams
Preferred skills
Advanced degree, FDA and international standards knowledge, clinical environment understanding
Technologies
Real-time embedded software systems, modem software development and QA tools
Responsibilities
Plan, budget, and schedule Design Quality Assurance teams for multiple concurrent projects; Establish policies for hardware and software QA integration; Lead development of system level V&V procedures including simulated use and stress tests; Review and approve QA procedures and testing results for product release; Develop standardized validation procedures; Participate in new product specification development; Investigate and resolve product design problems reported by customers
Seniority
Senior, hands-on IC with leadership responsibilities
