Job Description

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\xc2\xae 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 NPI and Validation Engineering Manager will be a critical part of the successful start-up and ongoing operation of Insulet\xe2\x80\x99s first manufacturing location in Malaysia. The new Johor Bahru plant will utilize world-class custom automation equipment to support a highly complex, high-volume operation building Insulet\xe2\x80\x99s Omnipod products. This individual will work with the local Malaysian Engineering team and automation suppliers for the startup, integration, and production ramp in Malaysia. Projects may include cost and quality improvements, line qualifications, new product introductions (NPI) and other as assigned by manager. As part of providing support to the Operations and Manufacturing Group, the candidate will also carry out root cause investigations using structured problem-solving tools and will author and review quality system documentation such as validations, work instructions, SOPs, non-conforming material investigations, and tool files.

Insulet Corporation (NASDAQ: PODD) is an innovative medical device company dedicated to making the lives of people with diabetes easier. Through its OmniPod 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 OmniPod technology platform for the delivery of subcutaneous drugs across multiple therapeutic areas.

Responsibilities:

• Lead Automation and Malaysia engineering validation teams to deliver pod manufacturing capabilities at new Malaysia site.
• Weekly Beat the Plan progress reports on project deliverables and timelines.
• Drive product and process improvements in support of Insulet\xe2\x80\x99s Operations (3) main objectives:
  • Best Quality
  • Highest Efficiency
  • Lowest cost
• Develop and drive continuous improvement efforts.
• Manage Insulet Automation suppliers and deliver new machines and machine improvements
• At all times maintain a cGMP compliant environment and operate within FDA guidelines for Class II Medical Device Manufacturing
• Manage suppliers and supervise the generation of the Master Validation Plan for Malaysia MFG including: validation/qualification protocols, coordinate the execution of the validation/qualification protocols and the review of validation/qualification final reports
• Support responsibility for all project phases from concept, specification, cost justification, project management, installation, training, qualification, implementation into manufacturing and support.
• Use standardized root cause investigation templates and problem-solving tools to carry out non-confirming material investigations
• Implement corrective and preventative actions
• Monitor and report yield and equipment up-time information; own the required efforts to ensure these KPIs are at or above target level
• Support new product introduction initiatives
• Travel to key suppliers to help them carry out critical investigations or improvement projects
• Carry out duties in a quality system environment
• Possesses strong mechanical analysis skills.
• Analyze a product using mechanical engineering methods such as FBD analysis and fundamental physics
• Interpret the mechanical properties of the selected material for product design and make recommendations for suitable alternatives.
• Perform other duties as required

Education and Experience:
Minimum Requirements:

• B.S. in Mechanical Engineering & 8-10 years Medical Device experience

Preferred Skills and Competencies:

• Proficient in all Microsoft Office tools
• Excellent Microsoft Excel and Data Analysis Skills \xe2\x80\x93 Minitab or JMP
• Proficient in Solidworks and drafting skills
• Comfortable troubleshooting mechanical equipment, both semi and fully automated
• Basic knowledge of common challenges with assembly of molded components
• Strong command of structured problem-solving tools
• Excellent project management skills
• Multi-language fluency preferred (English, Malay, Mandarin)

NOTE: This position requires on-site working (requires on-site office/plant/lab work). #LI-Onsite