Senior Manufacturing Engineer

Boston Scientific Medical Device (Malaysia) Sdn. Bhd.; Penang; On-site; MYR 100,000 - 130,000; Full time

Job summary

A leading medical device manufacturer in Penang is seeking a Senior Manufacturing Engineer to oversee manufacturing processes and documentation. The ideal candidate will have over 8 years of experience and strong leadership abilities. Responsibilities include ensuring product quality and developing manufacturing procedures. This role demands analytical skills, and experience in the regulated industry is preferred.

Qualifications

• At least 8 years of experience in related field.
• Prefer candidate from medical device or other regulated industry experience.
• Hands-on and action-oriented engineer.

Responsibilities

• Identify and commission key process equipment.
• Develop and modify manufacturing documentation.
• Ensure new products meet quality and cost goals.
• Provide calibration services to meet objectives.

Skills

Leadership

Problem-solving

Manufacturing documentation

Analytical skills

Cross-functional collaboration

Education

Bachelor’s degree in Mechanical Engineering

Job description

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 documentations, 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 task. Ability to coach, lead and enhance the productivity of technical reports within the business. Provide a structured framework for training of technical reports. 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 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.
• 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.
• 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.
• Researches, recommends, and acquires new standards and other capital equipment, providing detailed justifications and cost analysis as required.
• Develop technical engineering reports and complex technical calibration procedures and trains 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 aspect of Calibration activity.

Job Requirements

• Bachelor’s degree in Mechanical Engineering (preferable mechanical, Chemical or biomedical).
• At least 8 years of experience in related field.
• Prefer candidate from medical device or other regulated industry experience.
• Demonstrate ability to generate manufacturing documentation, specifications and technical reports in a concise manner, hands on and action‑oriented engineer with strong analytical skill.
• Skill required:
  • Leadership.
  • Exhibits strong engineering knowledge, problem‑solving skills.
  • Experienced in sustaining and production working environments.
  • Able to work collaboratively with cross‑functional teams.
  • Experience in the medical devices manufacturing industry is a plus.