- Penang, Malaysia
- On-site
- Full-time · Manager
- 10+ years
Lead Process Engineering team in Penang, Malaysia enabling production and development of Instruments and Accessories for use in robotic procedures worldwide.
Responsibilities
- Lead Process Engineering team (Manufacturing Engineering and Equipment Engineering) in Penang, Malaysia enabling production and development of Instruments and Accessories for use in robotic procedures worldwide
- Maintain and execute multi-year roadmap for capacity improvements including mid and high volume products
- Oversee the validation and qualification of manufacturing equipment and processes in compliance with medical device manufacturing standards (DQ/IQ/OQ/PQ/PPQ)
- Maintain compliance with medical device quality system including corrective action closure, discrepant material disposition, internal/external audits and Engineering Change Orders (ECO)
- Hire, train, mentor and evaluate personnel to ensure efficient operation of process engineering functions
Requirements
- Minimum BS degree in Engineering (Mechanical, Electrical / Electronics, Computer Science, Manufacturing , Biomedical or equivalent)
- Nice to have: Leadership
- Nice to have: Team building
- Nice to have: Analytical skills
- Nice to have: Quantitative process development