Senior Systems Engineer

A company is looking for a Senior Systems Engineer to support design improvement projects for a replacement infusion system for Parkinson's Disease therapy.

Key Responsibilities

Manage device design changes and interface with cross-functional teams to mitigate risks associated with electromechanical drug delivery devices

Conduct verification testing including planning, fixture development, and test execution

Lead root cause investigations and propose device refinements based on stakeholder feedback

Required Qualifications

Bachelor of Science degree in a technical or scientific field required (graduate degree preferred)

5+ years of experience in medical device development roles required, with prior experience in infusion systems desired

Proficiency in electro-mechanical medical device design requirements and risk management

Experience with medical device EU and FDA submission, launch, and support required

Familiarity with good documentation practices and cross-functional collaboration