Staff NPI Engineer

Insulet Malaysia SDN. BHD.; Malaysia; On-site; MYR 180,000 - 300,000; Full time

Job summary

Insulet Malaysia Sdn. Bhd. in Johor Bahru seeks an NPI Staff Engineer to lead New Product Introduction programs and engineering projects across the lifecycle, including design transfers, validation, and manufacturing readiness.

You will collaborate with Operations, Quality, R&D, and Supply Chain to drive process improvements, ensure regulatory compliance (FDA/ISO 13485/cGMP), and support high-volume manufacturing ramp-up. Strong problem-solving and project management are essential.

Qualifications

• Education and Experience: B.S. and 8+ years of medical device experience, preference in Mechanical, Electrical, or Industrial engineering.
• Strong project management skills with experience leading cross-functional NPI, technology transfer, equipment qualification, and process validation projects, including planning, execution, risk management, and delivery of results within established timelines.
• Experience with IQ/OQ/PQ execution and validation documentation.
• Knowledge of FDA 21 CFR Part 820, ISO 13485, cGMP, and risk management methodologies including PFMEA.
• Excellent understanding of structured problem-solving tools (e.g. DMAIC, Six Sigma Green Belt).
• Multi-language fluency (English and Mandarin minimum).
• Work experience at high-volume manufacturing line in cleanroom environment.

Responsibilities

• Report to the Senior Manager, NPI & Test Engineering and provide technical leadership, coaching, and mentoring to engineers and technicians.
• Lead and support New Product Introduction (NPI) programs, product transfers, and assigned engineering projects throughout the project lifecycle, including concept development, planning, qualification, validation, implementation, manufacturing readiness, production ramp-up, and sustaining support.
• Lead equipment qualification and process validation activities, including IQ/OQ/PQ execution and documentation.
• Collaborate cross-functionally with Operations, Quality, Manufacturing Engineering, R&D, Supply Chain, and external partners to support project execution and manufacturing objectives.
• Lead continuous improvement initiatives by utilizing structured problem-solving methodologies to investigate product, process, equipment, and manufacturing issues and implement effective corrective and preventive actions (CAPA) to improve quality, yield, equipment performance, and operational efficiency.
• Lead risk identification, assessment, and mitigation activities throughout NPI, validation, and production transfer projects using PFMEA, risk assessments, and structured risk management methodologies.
• Maintain a cGMP-compliant environment and ensure compliance with FDA, ISO 13485, and company Quality System requirements.
• Monitor project, quality, and operational metrics and drive actions required to achieve established performance targets.
• Author and review engineering documentation including validation protocols, reports, investigations, work instructions, SOPs, engineering assessments, and risk management documentation.
• Perform other duties as assigned.

Skills

Project management

Quality systems

Problem solving

English & Mandarin

Education

B.S. in Mechanical Engineering

Job description

Job Summary

The NPI Staff Engineer is a critical member of the NPI Engineering team and will play a key role in the successful start-up and ongoing operation of Insulet Malaysia Sdn. Bhd.'s manufacturing facility in Johor Bahru. The individual will support the introduction of new products, Design and process transfers, engineering builds, equipment qualifications, process validations, and continuous improvement initiatives to ensure successful manufacturing readiness and sustained operational performance. This role is responsible for planning, coordinating, including Engineering Builds, Design Verification Builds, and other product and process validation activities. The engineer will work closely with cross-functional teams including Operations, Manufacturing Engineering, Quality, R&D, Supply Chain, and external suppliers to ensure projects are delivered safely, efficiently, and in compliance with applicable quality and regulatory requirements. The successful candidate will apply structured problem-solving methods, engineering principles, and project management skills to drive quality, efficiency, and cost improvements while supporting manufacturing ramp-up and operational excellence.

The NPI Staff Engineer is a critical member of the NPI Engineering team and will play a key role in the successful start-up and ongoing operation of Insulet Malaysia Sdn. Bhd.'s manufacturing facility in Johor Bahru. The individual will support the introduction of new products, Design and process transfers, engineering builds, equipment qualifications, process validations, and continuous improvement initiatives to ensure successful manufacturing readiness and sustained operational performance. This role is responsible for planning, coordinating, including Engineering Builds, Design Verification Builds, and other product and process validation activities. The engineer will work closely with cross-functional teams including Operations, Manufacturing Engineering, Quality, R&D, Supply Chain, and external suppliers to ensure projects are delivered safely, efficiently, and in compliance with applicable quality and regulatory requirements. The successful candidate will apply structured problem-solving methods, engineering principles, and project management skills to drive quality, efficiency, and cost improvements while supporting manufacturing ramp-up and operational excellence.

Responsibilities

• Report to the Senior Manager, NPI & Test Engineering and provide technical leadership, coaching, and mentoring to engineers and technicians.
• Lead and support New Product Introduction (NPI) programs, product transfers, and assigned engineering projects throughout the project lifecycle, including concept development, planning, qualification, validation, implementation, manufacturing readiness, production ramp-up, and sustaining support.
• Lead equipment qualification and process validation activities, including IQ/OQ/PQ execution and documentation.
• Collaborate cross-functionally with Operations, Quality, Manufacturing Engineering, R&D, Supply Chain, and external partners to support project execution and manufacturing objectives.
• Lead continuous improvement initiatives by utilizing structured problem-solving methodologies to investigate product, process, equipment, and manufacturing issues and implement effective corrective and preventive actions (CAPA) to improve quality, yield, equipment performance, and operational efficiency.
• Lead risk identification, assessment, and mitigation activities throughout NPI, validation, and production transfer projects using PFMEA, risk assessments, and structured risk management methodologies.
• Maintain a cGMP-compliant environment and ensure compliance with FDA, ISO 13485, and company Quality System requirements.
• Monitor project, quality, and operational metrics and drive actions required to achieve established performance targets.
• Author and review engineering documentation including validation protocols, reports, investigations, work instructions, SOPs, engineering assessments, and risk management documentation.
• Perform other duties as assigned.

Minimum Requirements

• Education and Experience: B.S. and 8+ years of medical device experience, preference in Mechanical, Electrical, or Industrial engineering.
• Strong project management skills with experience leading cross-functional NPI, technology transfer, equipment qualification, and process validation projects, including planning, execution, risk management, and delivery of results within established timelines.
• Experience with IQ/OQ/PQ execution and validation documentation.
• Knowledge of FDA 21 CFR Part 820, ISO 13485, cGMP, and risk management methodologies including PFMEA.
• Excellent understanding of structured problem-solving tools (e.g. DMAIC, Six Sigma Green Belt).
• Multi-language fluency (English and Mandarin minimum).
• Work experience at high-volume manufacturing line in cleanroom environmentundefinedundefined.

Preferred Skills and Competencies

• Familiarity with cGMP, ISO 13485, and FDA 21 CFR Part 820 requirements.
• Ability to perform effectively in a fast-paced, high-volume manufacturing environment.
• Strong decision-making skills with the ability to evaluate risks, analyze information, and implement practical solutions.
• Excellent communication and interpersonal skills with the ability to collaborate effectively across cross-functional teams.
• Strong structured problem-solving skills and the ability to drive issues to resolution.
• Demonstrated initiative, accountability, and ownership in achieving project and business objectives.
• Strong planning, prioritization, and organizational skills with the ability to manage multiple tasks and competing priorities.

Physical Requirements (if applicable)

Able to work off shifts (nights/weekends) as needed, 10% max NOTE: This position requires on-site working (requires on-site office/plant/lab work).

Insulet started in 2000 with an idea and a mission to enable our customers to enjoy simplicity, freedom and healthier lives through the use of our Omnipod product platform. In the last two decades we have improved the lives of hundreds of thousands of patients by using innovative technology that is wearable, waterproof, and lifestyle accommodating. We are looking for highly motivated, performance driven individuals to be a part of our expanding team. We do this by hiring amazing people guided by shared values who exceed customer expectations. Our continued success depends on it! Insulet Corporation is proud to be an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran. (Know Your Rights)

Insulet employees are all focused on the same goal - to make a difference. Our relentless passion is to simplify life for people with diabetes. We excite and empower employees to bring their best selves to work through a culture that supports a healthy work and life balance. We set the bar high to meet customer needs, and our priority is to ensure our employees are equipped and supported to help us get there. We foster and celebrate curiosity, innovation, and learning. Our teams work collaboratively and are empowered to drive the best actions for our customers. Our innovation spirit and customer-centric focus position us as global pioneers - leading the way to improve health outcomes with revolutionary medical devices while breaking down barriers to access.