Sr. Staff NPI and Validation Engineer (On-site)

Job Title:                             Senior Staff NPI and Validation Engineer

Department:                     3510 – Engineering Management

FLSA Status:                      Exempt

Position Overview:

The Senior Staff NPI and Validation Engineer is a critical member of the Global NPI and Validation Engineering team. This role 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 is responsible for providing leadership for 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 is responsible for standardizing process validation processes, providing formal and informal training to global manufacturing engineering teams, supporting process development and Design of Experiment activities, and driving cost savings projects.

Regarding domestic support for international teams, this role is responsible for developing global processes for design transfer and manufacturing, planning engineering builds to support R&D activities, aligning on volume and forecast requirements with supply chain, and supporting the investigation of quality issues.

Responsibilities:

• Provide technical expertise and leadership for the Global NPI and Validation team and related cross functional teams
• Ensure the timely and effective launch of new products in the manufacturing space thru early collaboration with systems and R&D teams
• Provide validation expertise to manufacturing engineers to build departmental capability
• Drive 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
• Develop global processes for design transfer and manufacturing
• Work with supply chain to ensure manufacturing plants can meet volume and forecast requirements
• Autonomously interpret data to drive cost savings projects
• 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

Education and Experience:

• B.S. and 8+ years of medical device experience
• Excellent understanding of structured problem solving tools (e.g. DMAIC, Six Sigma, Black Belt)
• Expertise in validation of medical device manufacturing processes and equipment
• 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.

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, an