Senior Systems Verification Engineer

• Contribute to the planning, development and execution of system verification deliverables (test plans, test protocols, test cases, test reports, studies)
• Engage in test planning during design and development phases
• Contribute to the validation efforts for laboratory equipment supporting infusion system testing (e.g., Infuscale, altitude chambers, environmental chambers, and related test systems)
• Develop and execute validation protocols, test plans, and reports in alignment with FDA, ISO, and equipment validation best practices
• Perform IQ/OQ/PQ activities for lab equipment and ensure complete traceability from requirements through test execution
• Contribute to the development and documentation of system requirements, systems architecture and design
• Ensure appropriate traceability between system, subsystem, and software verification
• Manage the integration of deliverables from subsystem teams, multi-functional teams and external partners
• Resolve competing constraints between interrelated functions (Engineering, Risk Management, Compliance, Reliability, Clinical, Human Factors, Regulatory)
• Implement configuration and change management through the complete product life-cycle
• Build process improvements to streamline testing between system verification, subsystem and software verification
• Ensure all program achievements in support of all phases of the product development lifecycle are completed on time
• Participate and/or leads design reviews

• Bachelor’s Degree in Mechanical, Electrical, Computer Science, Biomedical Engineering or equivalent
• 3+ years of relevant industry experience
• Proven organization skills and ability to collaborate with both technical and non-technical personnel
• Solid understanding of ISO and/or FDA and other regulatory standards
• Knowledge of Design controls, Lifecycle testing processes, MTBF analysis
• Medical device industry experience is preferred

Medical device industry experience

• Support for Parents
• Continuing Education/ Professional Development
• Employee Heath & Well-Being Benefits
• Paid Time Off
• 2 Days a Year to Volunteer
• medical and dental coverage
• insurance coverage for basic life, accident, short-term and long-term disability, and business travel accident insurance
• Employee Stock Purchase Plan (ESPP)
• 401(k) Retirement Savings Plan (RSP)
• Flexible Spending Accounts
• educational assistance programs
• time-off benefits such as paid holidays, paid time off ranging from 20 to 35 days
• family and medical leaves of absence
• paid parental leave
• commuting benefits
• Employee Discount Program
• Employee Assistance Program (EAP)
• childcare benefits