Engineer II - Katalyst Healthcares & Life Sciences
Round Lake, IL 60073
About the Job
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.
- Safety Standards: Hands-on experience with safety standards (IEC 60601 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: B.E/B. Tech in Computer Science, Electronics & Communication, or Electrical Engineering.
- Experience: 2-6 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.
Source : Katalyst Healthcares & Life Sciences