Senior Manufacturing Support Engineer
Core
Senior Manufacturing Support Engineer leading process engineering, reliability, and continuous improvement initiatives for medical device manufacturing operations.
Role type
Senior Manufacturing Support Engineer (Process Engineering & Reliability)
Builds
FreeStyle blood glucose test strips and FreeStyle Sensors for diabetes management
Domain
Medical Devices / Diabetes Care / Highly Regulated Manufacturing
Required skills
Process engineering, Root cause analysis (DMAIC, 8D, Fishbone, 5 Whys), Lean Six Sigma, Risk management (PFMEA), Validation & Qualification, Regulatory compliance (FDA, ISO 13485, GMP), Data analysis, Technical mentorship
Preferred skills
Reliability engineering, Asset management, Predictive maintenance, Cross-functional leadership
Technologies
FDA regulations, ISO 13485, GMP, ISO 9001, CE Mark, DMAIC, 8D, Fishbone Analysis, Fault Tree Analysis, PFMEA, OEE
Responsibilities
Lead process improvement programmes to drive standardisation and efficiency; Conduct root cause investigations for product complaints and non-conformances; Develop and implement manufacturing processes to maximize quality and yield; Support equipment and process qualification activities including validation; Drive continuous improvement initiatives focused on process capability and waste reduction; Ensure compliance with quality, regulatory, and safety requirements.
Seniority
Senior, hands-on IC with leadership responsibilities