Senior Manufacturing Engineer

Boston Scientific; George Town; On-site; MYR 60,000 - 100,000; Full time

Job summary

An established industry player is seeking a Senior Manufacturing Engineer to enhance manufacturing processes and ensure product quality in a dynamic environment. The role involves developing documentation, leading process improvements, and collaborating with cross-functional teams to achieve operational excellence. Ideal candidates will possess strong analytical and interpersonal skills, with a commitment to patient safety and quality standards. This position offers the chance to make a significant impact in the medical technology field while working with innovative solutions that transform lives.

Qualifications

• 8+ years of process development/improvement experience in regulated industry.
• Proven ability to develop processes from concept to production.

Responsibilities

• Identify and commission key process equipment to meet business objectives.
• Develop and modify manufacturing documentation and procedures.

Skills

Analytical Skills

Interpersonal Skills

Project Management

Negotiation Skills

Problem Solving

Education

Bachelor’s degree in Mechanical Engineering

Bachelor’s degree in Biomedical Engineering

Tools

Six Sigma

Job description

Purpose Statement

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 and critical thinking skills, able to work well under general directions with minimal 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, coach, lead, and enhance the productivity of technical reports within the business. Provide a structured framework for training of technical reports and build collaborative relationships through strong teamwork across the organization.

Job Responsibilities

1. Identify, order, and commission key process equipment to CGMP in the Operations Engineering Cycle to meet key business objectives.
2. Serve as engineering process owner for the area.
3. Develop and modify manufacturing documentation and procedures to support commercial products and the introduction of new products to the production floor (assembly procedures, BOMs, etc.).
4. Ensure new products meet business, quality, output, and cost goals.
5. Develop and modify manufacturing processes to improve product and process quality and output.
6. Ensure product/process requirements are met for components, assemblies, tooling, and supplier specifications.
7. Perform product/process/vendor qualification activities as required.
8. Support material discrepancy review and disposition activities (MRB) for existing commercial products.
9. Develop expertise in a field to become a recognized leader or authority and apply this knowledge in leadership roles.
10. Eliminate or reduce product/process defects and improve yields. Solve technical problems from basic engineering principles, theories, and concepts.
11. Demonstrate a primary commitment to patient safety and product quality.
12. Support all quality and CAPA initiatives to achieve quality goals.
13. Maintain a valid capacity model in cooperation with the line supervisor and conduct advance planning for required capital.
14. Train cross-functional team members including engineers, technicians, and product builders.
15. Possess knowledge of project management.
16. Interact cross-functionally and with internal and external customers.
17. Develop expertise on BSC systems.
18. Willing to travel internationally for project work.

Additional Role for Calibration Engineering

• Provide equipment calibration services to meet company objectives, ensuring measurement traceability to recognized standards.
• Serve as SME for Calibration group and internal/external audits.
• Manage Calibration System and perform calibration functions daily.
• Research, recommend, and acquire new standards and equipment, providing justifications and cost analysis.
• Develop technical reports and calibration procedures, training technicians accordingly.
• Advise on equipment selection and design accommodations for calibration.
• Support calibration lab needs and work with management on budgets.
• Maintain compliance with quality requirements and drive standard work in calibration activities.

Job Requirements

• Bachelor’s degree in Mechanical Engineering, Biomedical Engineering, or related field.
• At least 8 years of process development/improvement experience.
• Experience in process development, equipment validation, and process characterization.
• Preferably from the medical device or regulated industry.
• Six Sigma Black Belt certification and experience with Design for Six Sigma tools.
• Ability to develop processes from concept to production and mentor junior staff.
• Excellent communication skills.

About Us

Boston Scientific, a global medical technology leader for over 40 years, aims to transform lives through innovative solutions that improve patient health. Join us to make a meaningful difference worldwide.