Engineering Lead

OUR COMPANY

• 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

• The Engineering Lead is responsible for the overall engineering execution of healthcare and IVD manufacturing transfer programs, ensuring successful product qualification, process validation, test readiness, regulatory compliance, manufacturing ramp-up, and customer satisfaction.
• The role directs cross-functional activities covering Process Engineering, Test Engineering, Quality Engineering, Manufacturing Engineering, Automation Engineering, regulatory compliance, and NPI program execution. The Engineering Lead serves as the primary technical interface between the customer and manufacturing site and is accountable for engineering readiness from technology transfer through mass production release.

KEY RESPONSIBILITIES

Program Leadership

• Lead the complete manufacturing transfer program from the customer site to the receiving production site.
• Establish the engineering project plan, resource model, ownership structure, milestones, and escalation process.
• Drive execution against schedule, quality, cost, compliance, and manufacturing-readiness objectives.
• Conduct engineering readiness reviews and recommend gate approval or recovery actions.
• Coordinate technical deliverables across Process, Test, Quality, Manufacturing, Automation, Facilities, EHS, and NPI teams.

Manufacturing Readiness

• Lead product, process, equipment, layout, capacity, tooling, material-flow, and workforce readiness assessments.
• Review product architecture, assembly sequence, process flow, production strategy, and scalability.
• Ensure work instructions, visual aids, process specifications, and manufacturing records reflect the approved operating method.
• Drive closure of DFM, DFA, documentation, tooling, ergonomic, and production-readiness gaps.

Validation Leadership

• Own the overall validation strategy covering IQ, OQ, PQ, equipment qualification, test-method validation, process validation, and software validation.
• Approve validation protocols, acceptance criteria, deviations, reports, and release recommendations before customer submission.
• Ensure validation traceability, objective evidence, risk controls, and change-impact assessments are complete and audit ready.

Process Engineering Leadership

• Direct process development, line setup, work-instruction development, tooling and fixture readiness, PFMEA, process capability, and change implementation.
• Assign process ownership across preparation, special processes, subassembly, main-unit integration, fluidics, optics, routing, and packout.
• Drive process stability, yield improvement, operator safety, cycle-time improvement, and non-value-added activity reduction.

Test Engineering Leadership

• Direct test strategy development for subassembly test, system-level test, parameter setting, HIPOT, burn-in, FQC, and production test readiness.
• Ensure tester hardware, fixtures, software, calibration, preventive maintenance, data collection, and validation are ready for production.
• Drive test correlation, false-failure reduction, failure analysis, tester availability, and test-yield improvement.

Regulatory, Quality and EHS Leadership

• Ensure engineering execution follows the applicable quality system, including ISO 13485, FDA quality-system expectations, change control, CAPA, traceability, and controlled records.
• Coordinate engineering support for customer audits, internal audits, regulatory readiness reviews, and manufacturing assessments.
• Ensure technical risks involving chemicals, waste, electrical safety, HIPOT isolation, lifting, ergonomics, and special equipment are assessed with Quality and EHS owners.

Customer and Stakeholder Management

• Act as the primary customer engineering focal point and lead technical review meetings.
• Present engineering status, readiness, risk, validation progress, recovery plans, and decisions requiring customer action.
• Drive closure of customer-owned technical gaps and escalate schedule, design, documentation, or compliance risks promptly.
• Support RFQ, transfer planning, capital justification, and manufacturing-release decisions.

Team Leadership and Capability Development

• Lead, coach, and mentor Process Engineers, Test Engineers, and Engineering Technicians assigned to the program.
• Define capability gaps, training plans, knowledge-transfer requirements, and succession coverage.
• Create clear technical ownership, decision authority, and measurable deliverables for each engineering workstream.

KEY DELIVERABLES AND DECISION GATES

• Engineering transfer plan and resource approval
• Manufacturing-readiness assessment and recovery plan
• Production line, equipment, tooling, and layout readiness approval
• IQ/OQ/PQ strategy, protocol, and report approval
• Process and test readiness approval
• Engineering build readiness and closure report
• Customer transfer acceptance support
• Mass-production release recommendation
• Post-launch stabilization and handover plan

TECHNICAL REQUIREMENTS

Engineering and Manufacturing

• Manufacturing engineering, process engineering, test engineering, automation, equipment qualification, production transfer, and system integration.
• Problem Solving and Analytics
• Root cause analysis, PFMEA, SPC, DOE, process capability, risk assessment, Lean manufacturing, and structured corrective action.

IVD Systems

• Working knowledge of fluidics, pumps, valves, reagent and sample handling, optics, sensors, motion control, actuators, analyzer integration, and production test.

Validation and Quality

• IQ/OQ/PQ, process validation, test-method validation, software validation, traceability, controlled documentation, CAPA, and change control.

Regulated Manufacturing

• Strong working knowledge of ISO 13485 and medical-device manufacturing controls; audit and inspection readiness experience preferred.

Leadership

• Technical leadership, program management, customer communication, cross-functional influence, conflict resolution, risk management, and executive reporting.

KEY REQUIREMENTS

• 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 of medical-device, healthcare, life-science, or similarly regulated manufacturing experience.
• 3+ years leading NPI, technology-transfer, validation, or complex manufacturing-readiness programs.
• Prior IVD analyzer, clinical diagnostic instrument, or Class II/III medical-device transfer experience is strongly preferred.
• FDA audit or inspection support, ISO 13485 auditor training, MDSAP knowledge, PMP, and Lean Six Sigma certification are preferred.