11 часов назад
Principal Systems Verification Engineer (Medical Devices)
112 000 - 154 000$
Мэтч & Сопровод
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Описание вакансии
Текст:
TL;DR
Principal Systems Verification Engineer (Medical Devices): Leading system verification and validation for infusion therapy products and laboratory equipment with an accent on regulated testing, traceability, and equipment qualification. Focus on designing verification plans, executing IQ/OQ/PQ activities, automating system testing, and guiding root-cause investigations under FDA and ISO requirements.
Location: Round Lake, Illinois, United States
Salary: $112,000–$154,000 annually, with potential eligibility for discretionary bonuses.
Company
develops healthcare products and infusion therapy solutions focused on saving and sustaining lives.
What you will do
- Lead the planning, development, and execution of system verification deliverables, including test plans, protocols, cases, reports, and studies.
- Lead validation of laboratory equipment used for infusion system testing, including Infuscale, altitude chambers, and environmental chambers.
- Develop and execute validation protocols and perform IQ/OQ/PQ activities in alignment with FDA, ISO, and equipment-validation practices.
- Maintain requirements-to-test traceability and contribute to system requirements, architecture, design, configuration management, and change management.
- Improve verification processes, automate system testing, and enhance the existing test automation framework.
- Provide technical leadership, mentor junior engineers, participate in design reviews, and guide investigations into root causes and corrective actions.
Requirements
- Bachelor’s degree in Mechanical, Electrical, Computer Science, Biomedical Engineering, or a related field.
- At least 5 years of relevant industry experience.
- Strong knowledge of ISO, FDA, and other regulatory standards, as well as design controls, lifecycle testing, and MTBF analysis.
- Strong organization and communication skills, including the ability to work with technical and non-technical stakeholders.
- Ability to lead teams across multiple sites and influence management with limited assistance.
- Must be authorized to work for any employer in the United States; visa sponsorship is not available.
Nice to have
- Medical device industry experience.
- Experience with test automation.
Culture & Benefits
- Full-time employment with medical and dental coverage beginning on the first day.
- Life, accident, disability, and business travel accident insurance.
- 401(k) retirement plan with company matching and an employee stock purchase plan.
- Educational assistance, paid holidays, paid time off, family and medical leave, and paid parental leave.
- Additional commuting, childcare, employee discount, and employee assistance benefits.
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