Engineering Lead - Healthcare & IVD Manufacturing Transfer

About the role

Jabil is hiring an Engineering Lead to own the engineering execution of healthcare and IVD manufacturing transfer programs. The role ensures product qualification, process validation, test readiness, regulatory compliance, manufacturing ramp-up and customer satisfaction, and acts as the primary technical interface between the customer and the manufacturing site.

Key responsibilities

• Lead the full manufacturing transfer program, set the project plan, milestones and escalation process, and drive execution against schedule, quality, cost and readiness objectives.
• Own the validation strategy (IQ, OQ, PQ, equipment, test-method, process and software validation) and approve protocols, acceptance criteria, deviations and reports before customer submission.
• Direct process engineering (line setup, work instructions, tooling, PFMEA, process capability) and test engineering (subassembly, system-level, burn-in, FQC, test readiness).
• Ensure engineering follows the quality system (ISO 13485, FDA expectations, change control, CAPA, traceability) and supports customer audits and regulatory readiness reviews.
• Lead, coach and mentor Process Engineers, Test Engineers and Engineering Technicians, and define training plans and succession coverage.
• Act as the customer engineering focal point, present engineering status and risks, and close customer-owned technical gaps.

Required profile

• Bachelor's degree in Mechanical, Electrical, Electronics, Biomedical, Manufacturing, Industrial or Mechatronics Engineering.
• 8 to 12+ years of engineering experience, including substantial manufacturing, process, test or systems-engineering responsibility.
• 5+ years in medical-device, healthcare, life-science or similarly regulated manufacturing.
• 3+ years leading NPI, technology-transfer, validation or complex manufacturing-readiness programs.
• Prior IVD analyzer, clinical diagnostic instrument or Class II/III device transfer experience strongly preferred.

Required skills

• Root cause analysis, PFMEA, SPC, DOE, process capability, Lean manufacturing and structured corrective action.
• Working knowledge of fluidics, pumps, valves, optics, sensors, motion control, actuators and analyzer integration.
• Strong working knowledge of ISO 13485 and medical-device manufacturing controls; audit and inspection readiness experience preferred.
• Preferred: FDA audit support, ISO 13485 auditor training, MDSAP knowledge, PMP and Lean Six Sigma certification.