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
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.
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