Design Engineer, New Haven

B.Sc.
/ B Eng degree in Engineering or Science or equivalent experience in regulated industry.
Preferable 7 years +' cGMP experience within quality in a medical device, SaMD R&D, ideally clinical phases through commercial
Understanding of Medical device development for the full lifecycle starting at the Design Control phases.
Knowledge of the regulatory and compliance requirements of design control for AI DHT / AI SaMD medical devices (FDA QSR 21 CFR Part 820 / ISO ***** and Regulation (EU) ********).
Demonstrated ability in decision making, problem solving and project management.
Collaborate, negotiate, influence and lead in a matrix organization
Excellent communication and interpersonal skills
Proven record in demonstrating agility