Engineer II

2 months ago


Round Lake, United States Katalyst HealthCares & Life Sciences Full time
Responsibilities: We are seeking an experienced Interoperability Engineer with expertise in Verification & Validation, System Integration, Connectivity, and the Design of Medical Devices. The ideal candidate will have a solid understanding of both wired and wireless connectivity technologies. 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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