Senior Engineering Manager

AMS; Kulim; On-site; MYR 200,000 - 300,000; Full time

Job summary

A leading medical device manufacturer in Malaysia is seeking an experienced engineering manager to oversee product development and manufacturing processes. The role involves managing a team, driving process optimization, and ensuring compliance with regulatory standards. Candidates should have a strong engineering background with at least 10 years in regulated manufacturing, including leadership experience. Proficiency in both English and Malay is required, along with a willingness to travel internationally as needed.

Qualifications

• Strong written and verbal proficiency in English and Malay language.
• Ability and willingness to travel internationally for extended periods, typically ranging from 1 to 2 months or more.

Responsibilities

• Manage and mentor a team of engineers during all phases of product development.
• Oversee design transfer from R&D to manufacturing, ensuring robust process validation.
• Provide technical leadership for manufacturing support and process optimization.

Skills

Management of Financial and Material Resources

Critical Thinking

Project Management

Collaboration and Productivity Software

Effective Communication Skills

Equipment & Process Engineering Optimization

Machining and Manufacturing Technologies

Data Science and Analysis

Lean Manufacturing

Continuous Improvement

Regulatory & Quality Compliance

Problem-Solving & Root Cause Analysis

Education

Bachelor’s engineering degree with 7+ years of relevant experience

Advanced engineering degree with 5+ years of relevant experience

Job description

Responsibilities

• Manage and mentor a team of engineers through all phases of product development, lifecycle management and product manufacturing.
• Oversee design transfer from R&D to manufacturing, ensuring robust process validation and documentation.
• Provide technical leadership for manufacturing support, equipment selection, and process optimization.
• Lead engineering activities for new product introduction, product transfer, process improvements, and cost reductions.
• Responsible for the development and implementation of activities in engineering technical areas to meet engineering goals, quality, and cost objectives.
• Makes budgetary recommendations on capital expenditures and direct/indirect labor.
• Develop talent through coaching, training, and performance management.
• Ability to lead, energize and influence change efforts at all levels of a complex organization.
• Develop and manage project timelines, budgets, and resources.
• Champion a culture of safety, quality, and operational excellence.
• Lead root cause analysis and corrective action for manufacturing and field issues.
• Supports the transfer of manufacturing products and the recruitment of new talent.
• Ensure the prioritization of strategic and department level initiatives to include defining performance goals and targets, conducting performance reviews, and staff 1:1s to guide performance management and employee development efforts and manage toward departmental goals.

Skills and Qualifications

Management Skills:

• Management of Financial and Material Resources
• Critical Thinking
• Project Management
• Management of Personnel Resources
• Collaboration and Productivity Software
• Effective Communication Skills

Functional Skills:

• Equipment & Process Engineering Optimization
• Machining and Manufacturing Technologies
• Proficient computer skills
• Data Science and Analysis
• Lean Manufacturing
• Continuous Improvement
• Regulatory & Quality Compliance
• Problem-Solving & Root Cause Analysis

• Bachelor’s engineering degree with 7+ years of relevant experience or an advanced engineering degree with 5+ years of relevant experience.
• Strong written and verbal proficiency in English and Malay language.
• Ability and willingness to travel internationally for extended periods, typically ranging from 1 to 2 months or more.

Desired Skills and Experience

• 10+ years in medical device or regulated manufacturing, including 5+ years leadership experience
• Experience and accountability driving change resulting in improvement of Safety, Quality, Delivery, and Cost KPIs.
• Demonstrated experience managing large, complex engineering transformation initiatives with high level of visibility and business criticality.
• Hands‑on experience managing cross-functional technical projects working across businesses, sites, or regions.
• Demonstrated experience working within a quality system or regulated industry, with a strong understanding of relevant documentation and quality requirements.
• Strong knowledge of design for manufacturability, process validation, and risk management.
• Experienced and familiar with Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ).
• Strong understanding of regulatory frameworks (FDA, EU MDR, ISO 13485).