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Senior Manufacturing Engineer

Work mode:  Onsite
Onsite Location(s): 

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.


Job Segment: Manufacturing Engineer, Medical Device Engineer, Medical Device, CAPA, Engineering, Healthcare, Management, Manufacturing

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