OE - Manufacturing Engineer (Automation / Assembly )
1 week ago
Company Overview
SHL Medical is the world-leading solution provider in the design, development, and manufacturing of advanced drug delivery systems with more than 5000 employees worldwide. Our customers include top pharmaceutical and biotech companies from around the globe that require innovative devices such as auto injectors or pen injectors to effectively deliver their drugs. Headquartered in Switzerland since late 2018, with sites in Sweden, Taiwan, and the Unites States.
Job Overview
This role is embedded in the Automation Technology Group within our Global Operations Engineering team in Taiwan.
Main Responsibilities
- Improve system & equipment reliability for the core processes to meet all customer, business & regulatory requirements
- Together with the rest of your team you will support the production for automated assembly of our autoinjector systems
- Lead engineering responsibility for production/product lines and corresponding assembly processes within our production system
- Collaborate closely with shopfloor production technicians, equipment builders and maintenance, quality and process development on performance/process improvements and trouble shooting
- Lead the development of improvement plans and requirements for capacity expansion and future assembly lines and production setups
- Lead improvement initiatives and capacity deployment in device assembly
- Responsible for manufacturing acceptance of new assembly lines / processes in regular production
- Lead validation activities for improving equipment quality, efficiency and safety relevant processes as necessary
- Support Design For Manufacturing (DFM) and definition of manufacturing requirements for new products
Required Skills & Qualifications
- Degree in Engineering or equivalent education/experience in a relevant field
- Hands-on manufacturing experience with highly automated high-volume production systems
- Hands-on experience with designing, developing and maintaining complex automated equipment is highly desirable
- Proven expertise in validation activities, following up on protocol preparation, report execution including IQ/OQ/PQ process.
- Knowledge of common problem-solving and Root Cause Analysis (RCA) methodologies; Six Sigma certification is a plus.
- Passionate & committed self-starter with "can do" attitude, team player and taking responsibility to get the job done
- Ability to work independent with strong attention to detail and focus on efficiency, effectiveness and cost
- Previous exposure to a highly regulated industry (e.g. medical, pharmaceutical) and knowledge of relevant standards (e.g. ISO13485, cGMP) is a plus
- Intercultural and interdisciplinary communication skills; able to communicate effectively in both Chinese and English (verbal, written)
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