Insulet Corporation
medical device
SrNPIandValidationEngineer
Neural analysis suggests this role is
optimal for Senior candidates.
“Sr NPI and Validation Engineer at Insulet Corporation. Skills: NPI, Validation Engineering, Design Transfer, Process Validation. Transition new products into manufacturing. Provide process validation expertise”
What You'll Achieve.
successful introduction of new products; cost savings projects; improve performance
Industry & Context.
structured problem solving tools; Problem Solving; Decision Making
Onsite, on-site office/plant/lab work
What They're Looking For.
Must Have
B. S., 5+ years of medical device experience, structured problem solving tools, validation of medical device manufacturing processes and equipment, data analysis tools, DOE, process development, Quality Management System (QMS), FDA guidelines for 21CFR820 manufacturing, ISO 13485
Nice to Have
ISO 13485, assembly methodologies, locational methods, assembly setup, pneumatic actuators, servo motors, limit switches, sensors, robotics, mechanical aptitude, technical drawings, technical manuals, cam driven linkages, discrete component assembly, automation, machine user interfaces (HMIs / GUIs)
What You'll Do.
Transition new products into manufacturing
Provide process validation expertise
Support global manufacturing engineering teams
Provide domestic support for international teams
Ensure Design for Manufacturing
Standardize design transfer processes
Coordinate Design Transfer activities
Standardize process validation processes
Support process development
Drive cost savings projects
Develop global processes
Plan engineering builds
Align on volume and forecast
Support investigation of quality issues
Ensure timely product launch
Provide validation expertise
Drive process improvements
Support equipment and process validation
Develop and deliver training
Ensure compliance with safety rules
Maintain cGMP compliant environment
Operate within FDA guidelines
Ensure compliance to ISO 13485
How You'll Work.
Team & Collaboration
Engaging with R&D teams; Providing support to global manufacturing engineering teams; Providing domestic support for international engineering teams; Working collaboratively under a Quality Management System (QMS); Develop intra-department teams; Work with supply chain; Support Global Manufacturing Engineering
Communication Scope
Communication Skills; interpersonal and communication skills
Process & Methodology
Planning Skills
Full Job Description
**Position Overview:** The Senior 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:** * 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 sav
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