Engineering Lead

At Jabil (NYSE: JBL) we are proud to be a trusted partner for the worlds 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.

Education and Experience

Bachelors 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.

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