Engineering Manager
Core
Plan, direct, and implement design and development of new medical device products, focusing on quality assurance, control systems, and manufacturing processes in extrusion and assembly.
Role type
Engineering Manager (Quality/Validation focus)
Builds
Medical device products and technical quality assurance/control systems
Domain
Medical Devices, Quality Engineering, Manufacturing
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Quality Engineering, Medical Device Design & Development, Extrusion & Assembly Manufacturing, Regulatory Compliance (21 CFR Part 820, ISO 13485, EU MDR, GMP), Risk Management (PHA, PFMEA, ISO 14971), CAPA & Non-Conformance Management, Process Improvement (DMAIC, RCA, 5Whys, Fishbone), Design of Experiments (DOE), Process Validation (IQ/OQ/PQ), Statistical Analysis (Minitab)
Technologies
Minitab
Responsibilities
Develop and maintain technical quality assurance and control systems; Select, develop, and evaluate personnel; Navigate government and industry regulations; Manage risk assessments and non-conformances; Leverage process improvement tools and DOE methods; Manage product validation (IQ/OQ/PQ)
Seniority
Manager, hands-on technical leadership
