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
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.
The Associate Engineer supports validation teams in ensuring new products, systems, or processes meet specified standards through documentation, testing, and data analysis under the guidance of senior staff.
The role requires maintaining compliance with regulatory guidelines such as GMP, FDA, ISO standards, and operating within a cGMP compliant environment.
Matching Summary
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.
Skills & Requirements
Must-have
validation plans and protocols
equipment and process validation
data analysis and interpretation
compliance with GMP and FDA standards
technical writing and documentation
cross-functional team collaboration
Nice-to-have
strong interpersonal and communication skills
planning and goal setting skills
collaboration with QA and manufacturing teams
cost savings project involvement
Key Requirements
knowledge of FAT, SAT, IQ, TMV, OQ and PQ validation activities
experience with FDA 21CFR820 manufacturing guidelines
understanding of ISO 13485 compliance
strong analytical and technical writing skills
demonstrated competency through education, training, or experience