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.
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