Boston, United States
$120,000 - $140000
Joshua Serlin (Cybernetic)
12 months ago
We are looking for a Lead Manufacturing Test Engineer to join our team. The lead manufacturing test engineer would be responsible for providing technical expertise in testing and product knowledge, writing test procedures and developing test plans, configuring necessary hardware and operating environments as needed to complete and execute assigned testing.
• Partner with R&D to set requirements for Product Test systems.
• Take the lead to specify, design and develop test systems and test protocols for a Medical Device or Life Science production system.
• Work with internal and external partners to develop, install and validate test systems and manufacturing systems.
• Support Test System Design & Validation with thorough documentation of User Requirements Specifications, Functional design specifications, IQ, OQ, FAT, SAT and PQ efforts.
- B.S. in related Engineering discipline, M.S. a plus
- 10+ years applicable experience in Test Development, Systems Engineering or Manufacturing.
- Working understanding of the principles of Medical Device and healthcare regulations including FDA’s Quality System Regulation (QSR) and European regulations.
- Experience in software validation a plus.
- Travel up to 25% may be needed