NPI and Validation Engineer

Job Summary

The NPI and Validation Engineer plays a key role in bringing new medical device products from development into manufacturing while ensuring processes are efficient, compliant, and high quality. This position partners closely with R&D to support design for manufacturability, leads and standardizes design transfer activities, and provides expertise in process validation (including equipment and manufacturing processes) across global teams. The role also drives process improvements and cost-saving initiatives through data analysis and structured problem-solving methods, while supporting international teams and addressing quality issues.

About the Role

Candidates should have a technical background with experience in medical device manufacturing, validation, and data-driven process development, along with strong collaboration, communication, and problem-solving skills, all while adhering to strict regulatory standards such as FDA and ISO 13485.

Responsibilities

• Ensure the timely and effective launch of new products in the manufacturing space thru early collaboration with systems and R&D teams
• Assists process improvements in support of Insulet’s primary manufacturing objectives: Best Quality, Best Service, Best Cost
• Support Global Manufacturing Engineering in all equipment and process validation activities: FAT, SAT, IQ, TMV, and PQ
• Provide domestic support for international teams
• Autonomously interpret data to drive cost savings projects
• 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

Requirements

• B.S. and 2+ years of relevant experience or master's with 1 year
• Experience with structured problem-solving tools (e.g. DMAIC, Six Sigma, Black Belt)
• Experience with validation of medical device manufacturing processes and equipment
• Experience 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.

Qualifications

• 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.
• Mechanical aptitude, technical ability, ability to read and understand technical drawings and manuals
• Techical knowledge of cam driven linkages, discrete component assembly, and automation
• Familiarity with machine user interfaces (HMIs / GUIs)
• Strong interpersonal and communication skills
• Excellent attention to detail, organizational skills, and rigorous process discipline
• Thirst for knowledge and intense curiosity
• 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.
• Work Organization – Takes a structured, economical approach to resources including time, people, money, and equipment.
• 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

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

Additional Information

Compensation & Benefits: For U.S.-based positions only, the annual base salary range for this role is $77,300.00 - $116,000.00 This position may also be eligible for incentive compensation. We offer a comprehensive benefits package, including:

• Medical, dental, and vision insurance
• 401(k) with company match
• Paid time off (PTO)
• And additional employee wellness programs

Application Details

To apply, please visit the Insulet Careers site and submit your application online. Actual pay depends on skills, experience, and education. Insulet Corporation (NASDAQ: PODD), headquartered in Massachusetts, is an innovative medical device company dedicated to simplifying life for people with diabetes and other conditions through its Omnipod product platform. The Omnipod Insulin Management System provides a unique alternative to traditional insulin delivery methods. With its simple, wearable design, the tubeless disposable Pod provides up to three days of non-stop insulin delivery, without the need to see or handle a needle. Insulet’s flagship innovation, the Omnipod 5 Automated Insulin Delivery System, integrates with a continuous glucose monitor to manage blood sugar with no multiple daily injections, zero fingersticks, and can be controlled by a compatible personal smartphone in the U.S. or by the Omnipod 5 Controller. Insulet also leverages the unique design of its Pod by tailoring its Omnipod technology platform for the delivery of non-insulin subcutaneous drugs across other therapeutic areas. For more information, please visit insulet.com and omnipod.com. 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!