Insulet Corporation

medical device

SrNPIandValidationEngineer

$95–142k Acton, Massachusetts, United States FULL TIME
Market Sentiment
HIGH DEMAND

Neural analysis suggests this role is
optimal for Senior candidates.

The Brief

“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.

medical device
Problems you'll solve

structured problem solving tools; Problem Solving; Decision Making

Eligibility Requirements

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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