Sr. Systems Engineer

Reason: The Combination and Medical Device Products team is developing a replacement infusion system for Parkinson s Disease therapy. We are in the design transfer and launch preparation phase of the project and are looking for high-performing and experienced Systems Engineer to support design improvement projects: design change impact assessments, requirement changes, risk management, design verification, traceability, and report deliverables.

Skills: Proficiency with electro-mechanical medical device design requirements, risk management, design verification and DHF traceability required. Proficiency with design change impact assessments, scoping design change projects, test execution, deviation reporting and management, data review and report writing is required. Experience with medical device EU and FDA submission, launch and support required. Proficiency in good documentation practices and cross-functional collaboration.

Responsibilities:
Manage device design changes by interfacing with cross-functional teams both at manufacturing partners and within client. Team member has full awareness of the potential consequences (defects and failure modes) of design changes to electromechanical drug delivery devices. Mitigates risk through strong technical acumen, detailed planning, and engineering confidence testing.
Verification testing (planning, fixture development, test method validation, protocol development, and test execution).
The team member will be responsible for multiple, often concurrent, projects including those involving external development partners.
Propose device refinements based upon patient feedback, manufacturing records, and feedback from other stakeholders.
Conduct analyses (e.g. calculations, tolerance analysis, etc.) as needed to improve product and component designs.
Lead and/or participate in root cause investigations and design solutions for complex engineering problems.
Responsible for compliance with applicable procedures, regulations, and standards (e.g. IEC 60601-1:2020, ISO 10993-1:2018).
Ensures quality and effectiveness of projects through sound design, early risk assessments, and implementation of fallback strategies.
Maintains device history file
Some travel may be required

Requirements: Bachelor of Science degree with 5+ years of experience in medical device development roles.

Desired: Graduate degree in a technical or scientific field. Prior experience with infusion systems (pumps and disposables) device development.
Environment: Electro-Mechanical medical device development office and laboratory settings.

Schedule: Eight hours a day, forty hours a week. Flexible schedule depending on the testing needs. There will be occasional overtime required, less than four hours a week.

On Site: Nearly all the work will be done on-site. There might be one day in two weeks that the candidate may be able to work from home to catch up documentation.