Senior Manufacturing Engineer

7 days ago

Penang, Malaysia Boston Scientific Gruppe Full time

Manufacturing Engineering Department seeking a Senior Manufacturing Engineer to perform all manufacturing engineering duties. The ideal candidate must possess effective verbal, written presentation, negotiation and interpersonal skills. Demonstrate ability to generate manufacturing documentation, specifications and technical reports in a concise manner, hands on and action-oriented engineer with strong analytical, critical thinking skills and able to work well under general directions with minimum supervision. The candidate should be data driven, goal oriented and willing to learn and develop new skills, able to work in a fast paced, time sensitive, multi-project and results driven environment with multi-disciplinary team interface. The ideal candidate must be able to plan and organize non-routine tasks. Ability to coach, lead and enhance the productivity of technical reports within the business. Build collaborative relationships through strong teamwork across the organization.

Job 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.
  • Support material discrepancy review and disposition activities (MRB) for existing commercial products.
  • Develop knowledge in a field to become a recognized leader or authority in an area of specialization and apply 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 cooperation 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.
  • Interact 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 set day to day function for calibration group.
  • Research, recommend, and acquire new standards and other capital equipment, providing detailed justifications and cost analysis as required.
  • Develop technical engineering reports and complex technical calibration procedures and train department technicians on new calibration procedures.
  • Work directly with Equipment Engineering and Manufacturing Engineering departments to advise on equipment selection, design accommodations for calibration of new equipment and appropriate measurement techniques.
  • Provide support and guidance to calibration technicians in performing complex equipment calibrations.
  • Support calibration lab needs regarding such issues as environmental control and new technologies.
  • Work with Management to develop the department fiscal year budgets.
  • Communicate 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 aspects of Calibration activity.
Job Requirements:
  • Candidate requires at least a Bachelor's degree in Mechanical Engineering or Biomedical Engineering or related engineering degree.
  • Candidate requires at least 8 years of demonstrated process development/improvement activities.
  • Process Development; equipment validations and process characterization and validation experience.
  • Prefer candidate from medical device or other regulated industry experience.
  • Required: Six Sigma Black Belt. Demonstrated use of Design for Six Sigma tools (DOE, problem solving, process improvement).
  • Demonstrated ability to develop processes from concept to production.
  • Guide and mentor junior on process and product development.

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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