Associate Engineer (12 Months Fixed Term Contract)

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!

Position Overview:

The Associate Engineer of Engineering in Malaysia will lead a team of Technicians, ensure their daily activities support business objectives, comply with cGMP requirements, and manage their performance/development. The Engineer of Test Engineering must put the safety of our people and patients first, be focused on quality, self-directed, a motivated team player, and a willing trainer—eager to gain and share new knowledge. The normal schedule for this role is Monday through Friday but the plant is a 24/7 operation and will require flexibility to maintain standards across all shifts.

Insulet Corporation (NASDAQ: PODD) is an innovative medical device company dedicated to making the lives of people with diabetes easier. Through its Omni Pod Insulin Management System, Insulet seeks to expand the use of insulin pump therapy among people with insulin-dependent diabetes.  Insulet's Delivery Systems business also partners with global pharmaceutical and biotechnology companies to tailor the Omni Pod technology platform for the delivery of subcutaneous drugs across multiple therapeutic areas. 

Responsibilities:

• Direct interaction with the manufacturing Personal Diabetes Monitor (PDM) and controls equipment including station set-up, calibration, validation and troubleshooting using electrical tools, measurement tools, machine documents, specialty gages, and high-speed filming equipment.
• Develop and deliver machines and process continuous improvements in support of Insulet’s primary manufacturing objectives: Best Quality, Best Service, Best Cost.
• Lead root-cause investigations for equipment related issues, deploy corrective actions and develop preventive actions to eliminate recurrence with PDM equipment.
• Collaborate with Cross-Functional Teams to investigate and rectify product defects, to ensure product quality is maintained.
• Responsible for creating and maintaining SAP Plant Maintenance functions related to equipment, including but not limited to Master Data, PM, Calibration, OOT Reports.
• Develop training plans and material, write SOPs, and verify activities are performed as specified in applicable documented procedures.
• Formally evaluates performance of team members and champions development of team. Manage attendance as part of team performance and coverage for absence/vacation requests.
• Build the capability of Technicians with the manufacturing equipment, controls and systems and establish daily work standards to maintain equipment reliability.
• Ensure compliance with safety rules, quality policies, and employee guidelines.
• Responsible for reporting safety, quality, and regulatory compliance concerns to leadership.
• Maintain a cGMP compliant environment, operate within FDA guidelines for 21CFR820 manufacturing, and ensure compliance with ISO 13485
• Perform other duties as required.

Minimum Requirements:

Education And Experience:

• Bachelor’s degree, or an equivalent combination of education and experience in electrical engineering or equivalent background.
• Minimum of 2 Years of experience with electronic engineering or relevant experience from the PCBA industry.
• Process oriented and uses data to make decisions.
• Ability to fulfill job responsibilities in a fast-paced/high-volume production environment.

Preferred Skills And Competencies:

• Strong PC skills and with industry language like C.
• Extensive knowledge in manufacturing test plans, electronic development and PCBA production, functionality, and interaction.
• Proficient in computer skills, MS Word, Excel, Power Point, Outlook.
• Requires electrical and software aptitude, technical ability, problem-solving skills, ability to read and understand technical drawings and manuals.
• Technical knowledge of cam driven linkages, discrete component assembly, and automation.
• Extensive experience with HMIs / GUIs.
• Previous experience working in a clean room environment.
• Experience working in a regulated industry; Consumer products or Life Sciences preferred.
• Strong interpersonal and communication skills.
• Excellent attention to detail, organizational skills, and rigorous process discipline.
• Ability to adapt quickly to changes in daily work plans and unplanned issues on equipment, maintaining a focus on productivity without compromising safety or quality.
• Thirst for knowledge and intense curiosity.
• Sound decision making using data.
• Multi-language fluency preferred (English, Malay)

Physical Requirements (If Applicable):

• Able to work all shifts and some weekends as required to support business objectives.
• Required to stand for at least 75% of working time per shift, with walking at least 50% of working time per shift.