Quality Engineer II – NPD
Core
Ensure compliance with regulatory requirements and oversee quality for new product development in transcatheter heart valve therapies.
Role type
Quality Engineer II (New Product Development)
Builds
Transcatheter Mitral and Tricuspid Therapies (TMTT) devices
Domain
Medical device manufacturing / Cardiovascular
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Design control documentation, Risk management, Usability engineering, Six Sigma, Lean methods, Process validation, CAPA analysis, FDA regulations knowledge
Preferred skills
CAD, Statistical techniques, Lab/industrial equipment operation
Technologies
MS Project, CAD
Responsibilities
Develop and maintain design control and risk management documentation; Optimize manufacturing processes using engineering methods; Collaborate with R&D and manufacturing on process validation and product launch; Investigate product quality and compliance issues; Train technicians on test procedures.
Seniority
Mid-level, hands-on IC