Insulet Corporation
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.
SALARY
$80K – $100K – 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
- 2+ years of experience with medical device manufacturing
- Experience with validation of medical device manufacturing processes and equipment
- Statistical and data analysis skills
- BS Degree
Company is an Equal Opportunity Employer and is committed to diversity in our workforce. EOE/M/F/D/V