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Senior Recruitment Consultant at HERO Recruitment Ltd. Senior Process Engineer - Medical Devices We're looking for an experienced Senior Process Engineer to join our team, driving process development and optimization for medical devices.
In this role, you'll enhance manufacturing processes, ensure compliance with industry standards, and lead process improvements across the team.
Key Responsibilities: Standardize and optimize process development methodologies.
Lead the scale-up of processes from pilot to full-scale production.
Develop, validate, and document manufacturing processes.
Ensure compliance with regulatory and quality standards (ISO 13485, FDA cGMP).
Implement Lean, Six Sigma, and other methodologies for continuous improvement.
Mentor junior engineers and technicians, fostering collaboration.
Manage technical projects, timelines, and risk assessments.
Required Qualifications: Bachelor's degree in Engineering (Mechanical, Biomedical, or related field).
6+ years of process development experience in the medical device industry.
Hands-on experience with process validation (IQ, OQ, PQ) and SPC.
Strong knowledge of medical device regulations and manufacturing technologies (injection moulding, automation, additive manufacturing).
Experience leading cross-functional teams and managing projects.
Preferred: Experience with DFM/DFA and cleanroom operations.
Seniority level Mid-Senior level
Employment type Full-time
Job function Engineering, Manufacturing, and Product Management
Industries Medical Equipment Manufacturing and Pharmaceutical Manufacturing
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