Ecocareers ยท 2 months ago
Senior Systems Engineer III
North Chicago, IL
Full-time
Onsite
Senior Level
5+ years expEcocareers is a company focused on developing innovative medical devices. They are seeking a Senior Systems Engineer III to support the design transfer and launch preparation phase of a replacement infusion system for Parkinson's Disease therapy, managing design changes and ensuring compliance with regulatory standards.
Staffing & Recruiting
Responsibilities
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
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
Qualification
Required
Bachelor of Science degree with 5+ years of experience in medical device development roles
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
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
Preferred
Graduate degree in a technical or scientific field
Prior experience with infusion systems (pumps and disposables) device development
Company
Ecocareers
Ecocareers provides a specialized job search for careers that make a difference.
2-10 employees
Funding
Current Stage
Early StageCompany data provided by crunchbase