Katalyst CRO ยท 2 months ago
Senior Systems Engineer III
Chicago, IL
Contract
Onsite
Senior Level
5+ years expKatalyst Healthcares & Life Sciences is focused on developing innovative medical devices, and they are seeking a Senior Systems Engineer III to support design improvement projects for a replacement infusion system for Parkinson's Disease therapy. The role involves managing device design changes, conducting verification testing, and ensuring compliance with applicable regulations while collaborating with cross-functional teams.
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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
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
Katalyst CRO
Katalyst CRO | Advancing Healthcare & Life Sciences with Expert Research & Regulatory Solutions Katalyst Healthcare & Life Sciences (Katalyst CRO) is a Global Contract Research and Knowledge Process Outsourcing Organization (CRO) dedicated to driving innovation in research, regulatory compliance, and quality excellence for pharmaceutical, biotechnology, and medical device companies worldwide.
51-200 employees
H1B Sponsorship
Katalyst CRO has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
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Trends of Total Sponsorships
2025 (37)
2024 (14)
2023 (24)
2022 (52)
2021 (54)
2020 (39)
Funding
Current Stage
Growth StageLeadership Team
John Patil
Recruiter, Pharma/CRO Staffing Division
Recent News
2024-04-07
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