Responsibilities:
- To ensure corporation’s software applications and equipment validating/qualifying to specifications.
- Submit specification, protocol and report for approvals and documentation control via a Change Request
- Monitors operations with an eye toward improving productivity and efficiency.
- Provide all necessary support to OT systems to ensure that all operating technologies are available, maintained, upgraded, and improved.
- OTE will also be involved in measuring and monitoring quality, integrity and accessibility of real-time information for both monitoring and control including regulatory data compliance.
- Designs efficient production processes and workflows using technology base foundation.
- Facilitate sessions around current state processes and define future state processes with monitoring systems in place.
- Evaluates data to implement technological improvements in production processes.
- Prepares critical spare part inventory analysis and register them to address production needs and cost optimization.
- Generates process documentation and reports.
- Ability to lead and manage cross-functional teams.
- Strong written and verbal communication skills are necessary for an Engineer. They must be aware of a business’s needs while making technical recommendations understandable.
- Collaborate with other departments and stakeholders to ensure that the solutions align with the organization's overall goals and objectives.
- Create SOPs, work instructions, process mapping, flowchart, control plan policies, reports, etc.
- Drives the Area Improvement Team Meeting to deliver pre-determined goals.
Requirements:
- BSc in Industrial Engineering or related field such as manufacturing or mechanical engineering, required.
- Knowledge of shop floor operation, processes, and standards in the field or medical device industry is added value.
- 3-5 years relevant work experience in a medical device manufacturing environment
- Project management skills
- Manage CI project and conduct assessment for shop – floor.
- Equipment spare part management experience
- Operational technology knowledge - software program and process
- Experience with lean manufacturing principles and continuous improvement methodologies
- Experience using System Applications and Products (SAP) software, MES, PIMS & (machine automation system if applicable)
- Experience conducting operational critical analysis
Perks & Benefits
- Employee equity
- Performance Bonus
- Allowance (travel stipends, transportation, etc.)
- Flexible working hours
- Medical insurance
- Personal development opportunities
- Paid training and development
- Remote work flexibility
Job Location
308b, Jln Perindustrian Bukit Minyak 18, Penang Science Park, 14100 Bukit Mertajam, Pulau Pinang
Click to view the location on Google maps
Company Summary
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