Engineer II, NPD- Quality
Core
Develop experiments and tests to validate and improve medical device manufacturing processes and products, ensuring compliance with regulatory requirements and quality systems.
Role type
Quality Engineer II (New Product Development)
Builds
Medical devices for cardiac surgery
Domain
Medical Devices / Cardiac Surgery
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Engineering principles, risk management, CAPA investigation, Six Sigma, LEAN, statistical techniques, lab/industrial equipment operation, quality systems adherence
Preferred skills
CQE certification, vendor management, stakeholder negotiation, process optimization
Technologies
None explicitly stated
Responsibilities
Develop and execute test protocols for product validation; Investigate manufacturing quality and compliance issues; Optimize manufacturing processes using engineering methods; Develop training and documentation for production; Assign support tasks and instruct technicians
Seniority
Mid-level IC
