NPI Senior Product Engineer

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.

Job Title: NPI Senior Production Engineer – Malaysia

Department: Engineering

Pay band: Grade 7

Reporting Manager: Senior Manager

Position Overview:

NPI Senior Product Engineer is a critical member of the NPI Engineering team. This role is responsible in the development and execution of engineering verification build projects, inclusive but not limited to Engineering Build, Verification Build, Characterization Build, Design Verification Build . The primary responsibility will be to manage and coordinate build requests, ensuring that all technical specifications and requirements are met. This role requires working closely with cross-functional teams, including design team, Material Supplier Engineering, manufacturing Engineering, and quality assurance, to streamline processes and optimize project timelines. This role is expertise in engineering principles and project management will be crucial in identifying potential issues and implementing effective solutions. This role demands strong analytical skills, attention to detail, and the ability to communicate complex technical information clearly. By driving efficiency and innovation, you will contribute significantly to the successful delivery of high-quality engineering projects.

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:

• Manage Engineering Build Requests: Oversee the entire lifecycle of engineering build requests, from initial submission to final delivery, ensuring all requirements are met.
• Conduct all verification builds to validate changes in materials, suppliers, processes, or test methods against current mass production standards. Ensure that changes do not affect product functionality, quality, or manufacturing process parameters.
• Collaborate with Cross-Functional Teams: Work closely with design, development, testing, and production teams to gather requirements, provide updates, and ensure seamless integration of builds.
• Build Process Optimization: Continuously evaluate and improve build processes to enhance efficiency, reduce errors, and streamline workflows.
• Documentation and Record Keeping: Maintain comprehensive documentation (Protocol and Report) of build requests, processes, and outcomes. Ensure all records are up-to-date and easily accessible.
• Issue Resolution: Identify, troubleshoot, and resolve build-related issues promptly to minimize downtime and ensure project timelines are met.
• Quality Assurance: Implement and enforce quality control measures to ensure all builds meet the required standards and specifications.
• Reporting and Communication: Provide regular updates and detailed reports on build status, progress, and any issues to stakeholders and management.
• Develop and deliver training to build the capability of plant engineering team as part of continuous improvement efforts
• Ensure compliance with safety rules, quality policies, and employee guidelines
• Maintain a cGMP compliant environment, operate within FDA guidelines for 21CFR820 manufacturing, and ensure compliance to ISO 13485
• Perform other duties as required

Minimum Requirements:

Education and Experience:

• B.S. and 5+ years of medical device experience, preference in Mechanical, Electrical, or Industrial engineering
• Excellent understanding of structured problem-solving tools (e.g. DMAIC, Six Sigma, Black Belt)
• Expertise in data analysis tools such as DOE and process development
• Experience and capability working collaboratively under a Quality Management System (QMS), ISO 13485 preferred
• 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.
• Multi-language fluency (English, Malay minimum)
• Work experience at high-volume manufacturing line in cleanroom environment

Preferred Skills and Competencies:

• Preferred familiarity with cGMP guidelines and ISO 13485 and FDA 21 CFR 820 regulations.
• Proficiency in computer aided design and standard computer/MSOffice systems. Fundamental knowledge of ERP systems.
• Able to fulfill job responsibilities in a fast-paced/high-volume production environment.
• A combination of education, training, and experience that results in demonstrated competency to perform the work may be substituted
• Hands-on technical ability with assembly methodologies including locational methods, assembly setup, pneumatic actuators, servo motors, limit switches, sensors, robotics, etc.
• Excellent attention to detail, organizational skills, and rigorous process discipline
• Decision Making – has a systematic and methodical approach to making decisions, seeks out and explores relevant information, thinks creatively beyond the immediate problem, assimilates facts quickly, challenges assumptions, and considers business implications of potential solutions.
• Communication Skills – Conveys information effectively, actively listens, resolves conflict constructively.
• Problem Solving – Uses a systematic, methodical approach to gather facts, define problems, generate, and implement solutions.
• Initiative – Makes decisions and takes actions appropriately. Willing to take risks as circumstances require.
• Planning Skills – Sets goals and priorities, thinks ahead, and identifies activities and resources needed to achieve goals.
• Perseverance – Achieves objectives by overcoming difficulties through tenacity and resilience.

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)