Senior Systems Engineer III

Senior Systems Engineer III

Join to apply for the Senior Systems Engineer III role at Katalyst CRO
.

• Support design improvement projects: conduct design change impact assessments, manage requirement changes, perform risk management, design verification, traceability, and deliver reports.
• Interface with cross‑functional teams at manufacturing partners and within the client to manage device design changes, ensuring awareness of potential defect and failure mode consequences.
• Perform verification testing including planning, fixture development, test method validation, protocol development, and test execution.
• Lead and/or participate in root cause investigations and design solutions for complex engineering problems.
• Propose device refinements based on patient feedback, manufacturing records, and stakeholder input.
• Conduct design analyses (e.g., calculations, tolerance analysis) to improve product and component designs.
• Maintain compliance with applicable procedures, regulations, and standards (e.g., IEC 60601‑1:2020, ISO 10993‑1:2018).
• Ensure quality and effectiveness of projects through early risk assessments and implementation of fallback strategies.
• Maintain device history file and documentation.
• Travel may be required.

• Bachelor of Science degree with 5+ years of experience in medical device development roles.
• Graduate degree in a technical or scientific field (desired).
• Prior experience with infusion systems (pumps and disposables) device development.
• Experience with EU and FDA medical device submissions, launch, and support.
• Proficiency in electro‑mechanical design requirements, risk management, design verification, DHF traceability.
• Proficiency in design change impact assessments, scoping design change projects, test execution, deviation reporting, data review, and report writing.
• Proficiency in good documentation practices and cross‑functional collaboration.
• Environment:
  Electro‑Mechanical medical device development office and laboratory settings.

Mid‑Senior level

Contract

Industries:
Pharmaceutical Manufacturing