Senior Manager, NPI Process Engineering &… at Ambu · Malaysia

As part of Ambu's Global R&D organization, the Senior Manager, NPI Process Engineering & Automation is responsible for leading the development, industrialization, and deployment of manufacturing processes, equipment, and automation solutions that enable successful new product introductions.

The role leads a multidisciplinary team of Process Engineers, Automation Engineers, and Equipment Engineers to ensure manufacturing processes are robust, scalable, validated, and ready for global production transfer.

This position serves as a key technical and people leader within the NPI organization, working closely with R&D, Operations, Quality, Supply Chain, and external suppliers to accelerate commercialization of new products while reducing manufacturing risk and cost.

Key responsibilities

Your main responsibilities will include:

Leadership and Team Development

• Lead, develop, and mentor a team of Process Engineering and Automation professionals
• Build organizational capability through coaching, succession planning, and technical competency development.
• Establish clear priorities, performance expectations, and resource plans to support the NPI portfolio.
• Foster a culture of collaboration, innovation, accountability, and continuous improvement.

Process Industrialization

• Lead development of manufacturing processes for new products from concept through commercialization.
• Ensure manufacturing processes are capable, repeatable, scalable, and suitable for high-volume production.
• Drive Design for Manufacturing (DFM), Design for Assembly (DFA), and Design for

Automation activities with R&D teams.

• Identify and mitigate manufacturing risks early in product development.

Equipment and Automation

• Lead specification, development, procurement, qualification, and deployment of manufacturing equipment and automation systems.
• Ensure automation strategies align with product, business, and operational requirements in collaboration with R&D and Operations
• Collaborate with internal teams and suppliers to develop innovative manufacturing solutions.
• Oversee machine acceptance, equipment performance, and readiness for production deployment.

Manufacturing Technology and Innovation

• Evaluate and implement advanced manufacturing technologies that improve productivity, quality, and cost performance.

• Drive technology assessments, feasibility studies, and proof-of-concept activities.

• Support development of manufacturing technology roadmaps for future product platforms.

• Benchmark industry best practices and emerging technologies.

• Project and Portfolio Management

• Provide technical leadership across multiple NPI projects simultaneously.

• Ensure engineering deliverables are executed according to quality, cost, and timeline requirements.

• Support project planning, resource forecasting, risk management, and issue resolution.

• Escalate critical technical or resource constraints when needed.

• Cross-Functional Collaboration

• Partner closely with R&D, Manufacturing Transfer, Process Validation, Operations, Quality, Regulatory Affairs, Supply Chain, and Procurement.

• Serve as the manufacturing process and automation representative within core project teams.

• Drive alignment between product requirements and manufacturing capabilities across global sites.

• Support production transfers between sites and contract manufacturing partners.

Compliance and Quality

• Ensure engineering activities comply with applicable medical device regulations, quality system requirements, and internal procedures.
• Support validation activities including process validation, equipment qualification, and manufacturing readiness reviews.
• Drive continuous improvement of engineering standards, methodologies, and documentation practices.

Suggested candidate profile

Skills and experiences can be earned in many different ways, and we understand that the best fit for the role cannot be prescribed on paper. You are however likely to succeed in this position if you:

Education

• Bachelor's or Master's Degree in Mechanical Engineering, Manufacturing Engineering, Industrial Engineering, Automation Engineering, Mechatronics, or related field.

Experience

• 10+ years of R&D, manufacturing engineering, process engineering, automation, or NPI experience.
• 5 - 10 years of leadership experience managing engineering teams.
• Experience industrializing complex medical devices, electronics, electromechanical products, or high-volume regulated products.
• Proven track record leading automation and equipment development projects.
• Experience working in a regulated environment such as Medical Device, Pharmaceutical, Life Sciences, Electronics, or similar industries.
• Experience working with global teams, suppliers, and manufacturing sites.

Priority will be given to candidates with:

• Experience with disposable medical devices and automated assembly processes.
• Knowledge of IQ/OQ/PQ, process validation, FDA, ISO 13485, and GMP requirements.
• Experience with machine vision, robotics, digital manufacturing, and Industry 4.0 technologies.
• Experience supporting global manufacturing scale-up activities.

Ambu – a visionary and international workplace where your efforts matter

Ambu is a company that expands rapidly and has ambitious growth targets. We meet these targets through interdisciplinary teamwork between motivated and highly skilled employees. Your contributions and efforts are crucial to our success and by joining us you will get the opportunity to work in an international head office with an informal working environment.

We offer great opportunities for personal development. Furthermore, we offer a wide range of professional, social and financial employee benefits in addition to exciting job challenges and continuous professional and personal development.