at Stefanini Group in Round Lake, Illinois, United States
Job Description
An Interoperability engineering professional with hands on experience in Verification & Validation, System Integration, Connectivity and Design of Medical Devices. Candidate should have 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 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.
Job Requirement:
- 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.
Qualifications & Skills:
- 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.
