Manager Engineering, NPD Quality
Core
Lead quality engineering strategy and execution for new product development to ensure compliance with global regulatory requirements and deliver innovative cardiovascular medical devices.
Role type
Manager, Quality Engineering (New Product Development)
Builds
Early-stage innovative cardiovascular products (valves, delivery systems, sheaths, catheters)
Domain
Medical Device / Cardiovascular / Regulatory Compliance
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Quality engineering, Quality management, Regulatory compliance, Team leadership, Project management, Risk management, Design control, Process improvement
Preferred skills
FDA/GMP/ISO knowledge, Usability engineering, Statistical methods (DOE, SPC, FMEA), Lean Manufacturing, Cross-functional collaboration, Technical documentation, Problem-solving
Technologies
Microsoft Office
Responsibilities
Lead quality engineering NPD strategy and execution; Manage and develop a high-performing team; Plan and direct operational and project activities; Drive continuous improvement and process enhancements; Oversee engineering activities and provide technical guidance; Create and maintain complex engineering documentation; Analyze and resolve complex technical issues.
Seniority
Manager, hands-on leadership
