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Engineer II

2 months ago

Round Lake, United States Katalyst Healthcares and Life Sciences Full time
Responsibilities:
  • n Interoperability engineering professional with hands on experience in Verification & Validation, System Integration.
  • Connectivity and Design of Medical Devices. Candidate should have a good understanding of connectivity technologies wired and wireless.
  • Develop test plans, test protocols, and test reports for Platform/System Level testing.
  • Perform the end to end and integration testing of Medical Devices.
  • Develop and maintain an effective and corroborative working relationship with internal and external development partners.
  • Interact with clinical and marketing to develop and refine user requirements.
  • Ensure user needs are captured, quality requirements are met and technical risks are mitigated from the Interoperability side.
  • Manage integration of deliverables from sub-system design teams and external partners.
  • Plan and execute system integration activities to minimize issues in systems validation.
  • Document traceability from requirements to verification activities for Interoperability Reports.
Requirements:
  • Hands on experience on Safety standards (IEC 60601 series) including collateral and particular standards.
  • Familiarity with regulatory requirements of FDA and EU MDR.
  • Strong team player, able to meet deadlines and handle changing priorities.
  • Experience in resolving complex technical problems using strong analytical skills.
  • Excellent written, oral and interpersonal skills.
  • Must be proficient at time management and multitasking.
  • B.E/B. Tech in Computer Science / Electronics & Communication / Electrical.
  • Strong communication skills - written & verbal.
  • 2-6 years of relevant technical experience in Validation & Verification, System Integration, defining systems and requirements for medical products.
  • Prior experience in Medication Delivery device domain, Medical Design experience with Infusion Pumps and Syringe Pumps is a plus.
  • Strong interpersonal skills with ability to work in a collaborative environment as well as independently with minimal supervision.