Interoperability Engineer

3 weeks ago


Round Lake Beach, Illinois, United States Katalyst HealthCares & Life Sciences Full time
Job Summary

Katalyst HealthCares & Life Sciences is seeking an experienced Interoperability Engineer to join our team. As an Interoperability Engineer, you will play a critical role in ensuring the seamless integration of medical devices and systems.

Key Responsibilities
  • Develop Testing Protocols: Create comprehensive test plans, protocols, and reports for platform and system-level testing.
  • Perform Testing: Conduct thorough end-to-end and integration testing of medical devices.
  • Collaborative Relationships: Foster effective and collaborative working relationships with internal and external development partners.
  • User Requirements: Work closely with clinical and marketing teams to develop and refine user requirements.
  • Quality and Risk Management: Ensure user needs are captured, quality requirements are met, and technical risks are mitigated from an interoperability perspective.
  • Integration Management: Oversee the integration of deliverables from sub-system design teams and external partners.
  • System Integration: Plan and execute system integration activities to minimize issues during systems validation.
  • Documentation: Maintain traceability from requirements to verification activities in interoperability reports.
Requirements
  • Safety Standards: Hands-on experience with safety standards (IEC series), including collateral and particular standards.
  • Regulatory Knowledge: Familiarity with FDA and EU MDR regulatory requirements.
  • Team Player: Strong team player who can meet deadlines and handle changing priorities.
  • Problem-Solving: Experience in resolving complex technical problems using strong analytical skills.
  • Communication Skills: Excellent written, oral, and interpersonal communication skills.
  • Time Management: Proficient in time management and multitasking.
  • Educational Background: Tech in Computer Science, Electronics & Communication, or Electrical Engineering.
  • Experience: - years of relevant technical experience in validation and verification, system integration, and defining systems and requirements for medical products.
  • Preferred Experience: Prior experience in the medication delivery device domain, specifically with infusion pumps and syringe pumps.
  • Interpersonal Skills: Ability to work collaboratively in a team environment as well as independently with minimal supervision.


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