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. 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.

Job Title:                        NPI and Validation Engineer

FLSA Status:                   Exempt

Position Overview:

The NPI and Validation Engineer is a critical member of the Global NPI and Validation Engineering team. This team is responsible for transitioning new products into manufacturing (design transfer), providing process validation expertise and support to global manufacturing engineering teams, and providing domestic support for international engineering teams.

Regarding design transfer, this role supports the successful introduction of new products, actively engaging with R&D teams to ensure Design for Manufacturing, standardizing design transfer processes, and coordinating Design Transfer activities globally.

Regarding process validation support, this role supports the standardization of process validation processes, supporting process development and Design of Experiment activities, and driving cost savings projects.

Regarding domestic support for international teams, this role supports the development of global processes for design transfer and manufacturing, planning engineering builds to support R&D activities, and supporting the investigation of quality issues.

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

Education and Experience:

• 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.

Preferred Skills and Competencies:

• 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.
• Technical knowledge of cam driven linkages, discrete component assembly, and automation
• Familiarity with machine user interfaces (HMIs / GUIs)
• Have 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: