Insulet Corporation
Sr. NPI & Validation Engineer
LOCATION
Acton, MA
COMPANY
Insulet started in 2000 with an idea and a mission to enable our customers to enjoy simplicity, freedom and healthier lives through the use of our Omnipod® product platform.
JOB SUMMARY
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.
SALARY
Starting at $120K -Commensurate with experience
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
QUALIFICATIONS
- 6+ years of experience with medical device manufacturing
- Experience with validation of medical device manufacturing processes and equipment
- Experience leading projects
- Statistical and data analysis skills
- BS in Engineering
Company is an Equal Opportunity Employer and is committed to diversity in our workforce. EOE/M/F/D/V