Senior Manufacturing Engineer
Penang, Malaysia
Key Responsibilities
- To identify, order and commission the key process equipment to CGMP in the Operations Engineering Cycle to meet key business objectives
- Engineering process owner for the area.
- Develop and modify manufacturing documentation and procedures to support commercial products as well as the introduction of new products to the production floor (assembly procedures, BOMs, etc.)
- Ensure that new products introduced to the production floor meet business, quality, output and cost goals and objectives
- Develop and modify various manufacturing processes to improve product and process quality and output
- Ensure product/process requirements are met for component, assembly, tooling and supplier specifications
- Perform product/process/vendor qualification activities as required
- Support material discrepancy review and disposition activities (MRB) for existing commercial products
- Develops knowledge in a field to become a recognized leader or authority in an area of specialization and applies this knowledge in leadership roles in the company
- Eliminate/reduce product/process defects and improve yields. Strong problem solver for technical problems in the area, solves problems from basic engineering principles, theories and concepts.
- Demonstrate a primary commitment to patient safety and product quality
- Support all quality and corrective/preventive actions initiatives (NCEP, CAPA) to achieve quality goals
- Maintain a valid capacity model in co-operation with the line Supervisor and conduct adequate advance planning for required capital
- Capable of training cross functional team members including, engineers, technicians and product builders
- Knowledge of project management.
- Interacts cross functionally and with internal and external customers.
- Ability to develop expert knowledge on BSC systems.
- Willing to travel internationally as part of project team.
- For individual who is assigned calibration engineering role only:
- Provide equipment calibration services necessary to meet company objectives, while assuring measurement traceability to nationally recognized equipment calibration standards and
- practices.
- Technical SME for Calibration group and SME for internal and external Audit
- SME for Calibration Management System
- Perform calibration functions and sets day to day function for calibration group
- Researches, recommends, and acquires new standards and other capital equipment, providing detailed justifications and cost analysis as required.
- Develops technical engineering reports and complex technical calibration procedures and trains department technicians on new calibration procedures.
- Works directly with Equipment Engineering and Manufacturing Engineering departments to advise on equipment selection, design accommodations for calibration of new equipment and appropriate measurement techniques.
- Provides support and guidance to calibration technicians in performing complex equipment calibrations.
- Supports calibration lab needs regarding such issues as environmental control and new technologies.
- Works with Management to develop the department fiscal year budgets.
- Communicates with the Operations ME function on calibration status.
- Build Quality into all aspects of work by maintaining compliance to all quality requirements
- Drive “Standard Work” in all aspect of Calibration activity
Requirements
- Minimum Degree in Engineering
- 9-12 years of experience in manufacturing / process engineering. Prior experience in the medical device industry is preferred.
- Required skills: Problem Solving, analytical skill, project management, critical thinking, NPI, people leadership, direct reports management.
- Proven track record in product transfers, equipment qualification, and process validation.
- Experience in working within a matrix organization and cross-site collaboration.
- Strong project management and technical documentation skills.
- Proficient in validation protocol/report writing (IQ/OQ/PQ).
- Skilled in root cause analysis and process improvement methodologies .
- Effective communication and stakeholder management across global teams
- Experience in product transfer will be added advantage.
About Us
As a global medical technology leader for more than 40 years, our mission at Boston Scientific (NYSE: BSX) is to transform lives through innovative medical solutions that improve the health of patients. If you’re looking to truly make a difference to people both around the world and around the corner, there’s no better place to make it happen.
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Manufacturing Engineer, Medical Device Engineer, Medical Device, CAPA, Engineering, Healthcare, Management, Manufacturing