Insulet seeks an Associate Test Engineer to lead a technician team, ensuring cGMP compliance and equipment reliability in a 24/7 manufacturing environment.
Your role
Key responsibilities include:
- Lead a team of Technicians, managing daily activities, performance, and development.
- Interact directly with manufacturing insulin pump and controls equipment for setup, calibration, validation, and troubleshooting.
- Develop and implement continuous improvements for machines and processes to meet quality, service, and cost objectives.
- Lead root‑cause investigations for equipment issues, deploy corrective and preventive actions.
- Collaborate with cross‑functional teams to investigate and resolve product defects.
- Create and maintain SAP Plant Maintenance functions including Master Data, PM, Calibration, and OOT Reports.
- Develop training plans and materials, write SOPs, and verify compliance with documented procedures.
- Evaluate team member performance, manage attendance, and ensure coverage for absences.
- Build technician capability on manufacturing equipment and establish daily work standards.
- Ensure compliance with safety rules, quality policies, and employee guidelines.
- Report safety, quality, and regulatory compliance concerns to leadership.
- Maintain a cGMP compliant environment, operate within FDA 21CFR820 and ISO 13485 guidelines.
- Perform other duties as required.
About you
The company is looking for:
- Bachelor’s degree or equivalent in electrical engineering or related field.
- Fresh graduate or 1 year experience in electronic engineering or PCBA industry.
- Process‑oriented with data‑driven decision‑making skills.
- Ability to work in a fast‑paced, high‑volume production environment.
- Strong PC skills and familiarity with industry language like C.
- Knowledge of manufacturing test plans, electronic development, PCBA production, and equipment functionality.
- Proficient in MS Word, Excel, PowerPoint, Outlook.
- Electrical and software aptitude, problem‑solving skills, ability to read technical drawings and manuals.
- Technical knowledge of cam driven linkages, discrete component assembly, and automation.
- Experience with HMIs / GUIs and clean room environments.
- Experience in regulated industries such as consumer products or life sciences preferred.
- Strong interpersonal and communication skills.
- Excellent attention to detail, organizational skills, and process discipline.
- Ability to adapt quickly to changes and maintain productivity without compromising safety or quality.
- Curiosity and eagerness to learn.
- Sound data‑driven decision‑making.
- Multi‑language fluency preferred (English, Malay).
- Willingness to work all shifts and some weekends as required.
- Physical ability to stand for at least 75% and walk 50% of the shift.
Training & development
- Develop training plans and materials for team members.
- Champion team development and capability building on manufacturing equipment and systems.
This job may close before the stated closing date, you are encouraged to apply as soon as possible.