Process / Manufacturing Engineer II (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 Owns assigned manufacturing processes, drives yield improvement, supports NPI and manufacturing transfer, and leads validation activities for medical device and IVD products. Technical Requirements Advanced Manufacturing Engineering • Develop, optimize and sustain manufacturing processes for assigned product lines. • Support DFM reviews, assembly optimization, equipment qualification and workstation design. • Perform process capability studies and define improvement actions. Lean and Continuous Improvement • Lead value stream mapping, DMAIC, Kaizen, waste elimination and OEE improvement activities. • Drive cost reduction projects through process simplification, layout improvement and equipment utilization. • Use data-driven methods to improve line efficiency, yield and production stability. Validation Expertise • Own IQ/OQ/PQ activities for assigned equipment, processes or production areas. • Perform Gauge R&R, process capability analysis, risk assessment and FMEA updates. • Prepare validation reports, process release evidence and manufacturing readiness documentation. Medical Device Compliance • Apply ISO 13485 and FDA 21 CFR Part 820 requirements in daily engineering work. • Support change control, CAPA, deviation management, traceability and DHR requirements. • Participate in internal audits, customer audits and regulatory readiness activities. IVD-Specific Knowledge • Support processes involving fluidics assemblies, optics modules, motion control systems, reagent handling and environmental control requirements. • Troubleshoot process-related failures on IVD analyzers or medical device equipment. Education and Experience • Bachelor Degree in Mechanical, Manufacturing, Industrial, Biomedical, Mechatronics or related Engineering. • 3 to 5 years of manufacturing, process or industrial engineering experience. • 2+ years of medical device, healthcare or IVD manufacturing experience preferred. • Experience supporting NPI transfer and validation activities. 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