Systems Design / Product Development Engineer

ICONMA, LLC

Warsaw, IN(remote)

JOB DETAILS
SALARY
$48.80–$53.46 Per Hour
SKILLS
Analysis Skills, Atlassian JIRA, Biomedical Engineering, Clinical Practices/Protocols, Communication Skills, Cross-Functional, Documentation, FDA (Food and Drug Administration), Health Plan, Healthcare, ISO (International Organization for Standardization), International Electro-Technical Commission (IEC), Machine Tool, Maintain Compliance, Medical Equipment, Presentation/Verbal Skills, Product Design, Product Development, Product Engineering, Quality Assurance, Regulations, Requirements Management, Research & Development (R&D), Risk, Risk Analysis, Software Specification, Test Case, Test Plan/Schedule, Traceability, Usability Engineering, Writing Skills
LOCATION
Warsaw, IN(remote)
POSTED
4 days ago
Our client, a Medical Devices/Healthcare company, is looking for a Systems Design / Product Development Engineer for their Salt Lake City, UT/Remote location.
 
Responsibilities:
  • Draft and maintain DHF content including user needs, system/design requirements, software requirement specifications, design inputs, traceability matrices, and risk
  • documentation
  • Support risk analysis activities (e.g. FMEAs) and contribute to usability engineering activities
  • Support V&V activities including drafting, execution and creation of test cases, reports and other testing artifacts
  • Collaborate cross-functionally with R&D, QA, Clinical, and Regulatory to translate technical information across stakeholder groups
 
Requirements:
  • 5+ years of experience in systems design/product development within a multi-disciplinary organization
  • Demonstrated experience with SaMD development and regulatory documentation
  • Working knowledge of ISO 14971; familiarity with ISO62304 and IEC 62366 preferred
  • Experience drafting DHF artifacts (user needs, requirements, traceability matrices, risk files)
  • Experience in a regulated, compliance-driven environment (FDA/QMS)
  • Strong analytical skills and sound technical judgment
  • Excellent written and verbal communication skills, with ability to work effectively with internal and external collaborators
  • Experience with Codebeamer, JIRA, or similar requirements/traceability tooling
  • Bachelor's degree in Engineering or a related science field; Biomedical Engineering preferred
 
Why Should You Apply?

About the Company

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ICONMA, LLC