Associate Engineer, Maintenance Operations

Insulet Corporation; Malaysia; On-site; MYR 60,000 - 90,000; Full time

Job summary

Insulet Corporation is seeking an Associate Engineer to support equipment reliability and TPM initiatives across manufacturing operations in Malaysia. You will drive maintenance governance, training, and process optimization while collaborating with Production, Quality, Maintenance, and Engineering teams.

The role requires strong analytical, communication, and technical writing skills, with a focus on data-driven improvements and cGMP/ISO 13485 compliance.

Qualifications

• Bachelor’s degree in engineering or Life Sciences from an accredited program.
• Basic proficiency in MS Office and data analytics tools; exposure to DOE.
• Experience or education in structured problem-solving tools (e.g., DMAIC, Six Sigma, Black Belt).

Responsibilities

• Coordinate and maintain engineering transcripts, competency, training governance and qualification programs.
• Maintain site Maintenance Academy program including training coordination and certification.
• Support preventive maintenance excellence through standards, documentation governance, and compliance.
• Participate in TPM and reliability improvement activities (autonomous maintenance, planned maintenance, predictive maintenance).
• Contribute to Lean/Six Sigma/Kaizen initiatives to improve equipment performance.
• Analyze maintenance and operational data to identify improvement opportunities.
• Maintain engineering records and change control in accordance with procedures.
• Collaborate with Production, Quality, Maintenance, and Engineering teams.
• Maintain a cGMP environment and comply with FDA 21 CFR 820 and ISO 13485.
• Perform other duties as assigned.

Skills

Analytical skills

Communication

Technical writing

Cross-functional collaboration

Data analysis

Education

Bachelor’s degree in engineering or Life Sciences

Tools

MS Office (Word, Excel, PowerPoint, Outlook)

Data analytics tools (DOE)

Job description

Job Summary Position Overview

The Associate Engineer support equipment reliability, TPM implementation, maintenance excellence programs, technician competency development and process optimization initiatives across manufacturing operations. Serves as the focal person for Maintenance Academy, Engineering Transcript management, maintenance documentation governance, and TPM activities while supporting equipment performance improvement and manufacturing process optimization. The (AE) must be proficient in strong analytical, communication, and technical writing skills, as well as attention to detail and the ability to work with cross-functional teams.

Responsibilities

• Coordinate and maintain engineering transcript, competency, training governance, and qualification programs, including training records, competency assessments, and workforce development activities.
• Coordinate and maintain site Maintenance Academy program through training coordination, competency tracking, technician certification, and capability development initiatives.
• Support preventive maintenance excellence initiatives by maintaining maintenance standards, documentation governance, compliance requirements, and maintenance best practices.
• Participate in TPM and reliability improvement activities, including Autonomous Maintenance, Planned Maintenance optimization, predictive maintenance and continuous improvement programs.
• Participate in Lean Manufacturing, Six Sigma, Kaizen, and process optimization initiatives to improve operational performance and equipment effectiveness.
• Analyze maintenance and operational data to identify improvement opportunities and support corrective actions.
• Maintain engineering records, maintenance documentation, and change control records in accordance with company procedures.
• Collaborate with Production, Quality, Maintenance, and Engineering teams to support equipment reliability, process improvement, and operational excellence initiatives.
• Maintain a cGMP compliant environment, operate within FDA guidelines for 21CFR820 manufacturing, and ensure compliance to ISO 13485.
• Perform other duties as assigned.

Education and Experience

Bachelor’s degree in engineering (e.g., Chemical, Mechanical, Electrical), Life Sciences, or a related field. Basic proficiency in MS Office (MS Word, Excel, Power Point, Outlook) and data analytics Tools. Exposure or academy education in data analysis tools such as DOE and process development. Exposure or academy education in structured problem-solving tools (e.g. DMAIC, Six Sigma, Black Belt). Exposure to manufacturing, maintenance, reliability, TPM, or process improvement activities in pharmaceutical, medical device, or related industries.

Minimum Requirements

Preferred Skills and Competencies: Analyze data, identify issues or non-conformances, and recommend or implement corrective actions to improve process efficiency and product quality. The ability to analyze data using various operating systems and programs and to develop intra-department teams to establish goals and take corrective actions to improve performance. Collaborate with Production, Quality, Maintenance, and Engineering teams to support equipment reliability, maintenance excellence, and process improvement initiatives. A combination of education, training, and experience that results in demonstrated competency to perform the work may be substituted. Have strong interpersonal and communication skills. Communication Skills – Conveys information effectively, actively listens, resolves conflict constructively. Planning Skills – Sets goals and priorities, thinks ahead, and identifies activities and resources needed to achieve goals.

Physical Requirements

Able to work off shifts (nights/weekends) as needed, 10% max.

Company Overview

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.