Test Engineer III (IVD / Medical Device)

Job description

At Jabil (NYSE: JBL), we are proud to be a trusted partner for the world's top brands, offering comprehensive engineering, supply chain, and manufacturing solutions. With 60 years of experience across industries and a vast network of over 100 sites worldwide, Jabil combines global reach with local expertise to deliver both scalable and customized solutions. Our commitment extends beyond business success as we strive to build sustainable processes that minimize environmental impact and foster vibrant and diverse communities around the globe. Position Summary Acts as the technical leader for test engineering activities related to medical devices and IVD systems. Leads NPI, test technology development, validation strategy, customer engagement, audit readiness, and continuous improvement initiatives. Key Responsibilities Technical Leadership • Lead, coach, and guide Test Engineer I and II resources. • Establish test engineering standards, best practices, and training plans. • Review technical solutions, validation plans, and test readiness deliverables. • Drive cross-functional problem solving with Manufacturing, Quality, Process, IT, and Customer teams. Test Architecture Ownership • Define overall test strategy for assigned medical or IVD programs. • Approve test station design, measurement approach, validation strategy, and automation architecture. • Evaluate and implement new test technologies for quality, efficiency, and compliance improvement. IVD Subject Matter Expertise • Serve as SME for IVD analyzer testing such as hematology, urinalysis, immunoassay, molecular diagnostics, optical detection, fluidics, motion control, and robotic subsystems. • Lead complex failure analysis on integrated instrument systems. • Assess technical gaps during customer transfer and manufacturing readiness reviews. Regulatory and Audit Leadership • Lead FDA, ISO 13485, MDSAP, and customer audit support related to test engineering. • Approve validation deliverables and ensure inspection readiness. • Review risk assessments, change controls, CAPA actions, and validation impact assessments. Customer Interface • Act as technical escalation point for assigned customer programs. • Lead customer technical reviews and present validation or test performance results. • Support RFQ responses, transfer planning, and manufacturing readiness strategy. Technical Requirements • Expert knowledge of test architecture, system-level diagnostics, failure analysis, design for testability, automated test platforms, and production data analytics. • Advanced skills in LabVIEW, NI TestStand, Python, C#, database integration, MES integration, and automated reporting preferred. • Strong knowledge of ISO 13485, FDA 21 CFR Part 820, IQ/OQ/PQ, process validation, risk management, ISO 14971, CAPA, and design/process change control. Education and Experience • Bachelor Degree in Engineering; advanced degree is preferred but not mandatory. • 5 to 8+ years of test engineering experience. • 3+ years of medical device or IVD analyzer experience preferred. • Demonstrated ownership of NPI, validation programs, customer transfer, and audit support BE AWARE OF FRAUD: When applying for a job at Jabil you will be contacted via correspondence through our official job portal with a jabil.com e-mail address; direct phone call from a member of the Jabil team; or direct e-mail with a jabil.com e-mail address. Jabil does not request payments for interviews or at any other point during the hiring process. Jabil will not ask for your personal identifying information such as a social security number, birth certificate, financial institution, driver’s license number or passport information over the phone or via e-mail. If you believe you are a victim of identity theft, contact your local police department. Any scam job listings should be reported to whatever website it was posted in. Jabil, including its subsidiaries, is an equal opportunity employer and considers qualified applicants for employment without regard to race, color, religion, national origin, sex, sexual orientation, gender identity, age, disability, genetic information, veteran status, or any other characteristic protected by law. Accessibility Accommodation If you are a qualified individual with a disability, you have the right to request a reasonable accommodation if you are unable or limited in your ability to use or access Jabil.com/Careers site as a result of your disability. You can request a reasonable accommodation by sending an e-mail to Always_Accessible@Jabil.com with the nature of your request and contact information. Please do not direct any other general employment related questions to this e-mail. Please note that only those inquiries concerning a request for reasonable accommodation will be responded to. #whereyoubelong