Sr Process / Manufacturing Engineer (IVD / Medical Device)

Position Summary

Acts as technical authority for manufacturing processes, technology transfer, process validation, equipment strategy and operational excellence for medical device and IVD manufacturing operations.

Technical Requirements

Manufacturing Strategy

• Define end-to-end manufacturing architecture, production scaling strategy and capacity planning approach.

• Lead technology transfer, manufacturing readiness and process standardization for new or transferred products.

• Develop automation strategy and evaluate advanced manufacturing technologies.

Advanced Technical Skills

• Lead complex root cause analysis using structured problem-solving methods.

• Apply SPC, DOE, process simulation, operations research and business case analysis.

• Drive high-impact improvement projects involving cost, quality, output, reliability and manufacturability.

Validation Leadership

• Define validation master strategy and approve IQ/OQ/PQ approach.

• Lead process validation strategy, equipment qualification strategy and validation risk assessment.

• Prepare the site for customer audits, ISO audits, FDA readiness reviews and regulatory inspections.

Medical Device Regulatory Expertise

• Serve as SME for ISO 13485, FDA inspection readiness, MDSAP awareness, design transfer and process validation expectations.

• Review change control impact, CAPA effectiveness, risk assessment and technical file support needs.

IVD Manufacturing Expertise

• Lead manufacturing readiness for hematology systems, urinalysis analyzers, immunoassay platforms and molecular diagnostic instruments.

• Provide technical direction for automated sample handling, precision dispensing, optical measurement, fluidics and motion control processes.

Leadership and Customer Interface

• Coach engineers and technicians, lead cross-functional problem solving and represent manufacturing engineering in customer technical reviews.

• Support RFQ, capacity model, line design, capital planning and transfer execution.

Education and Experience

• Bachelor Degree in Engineering; advanced degree is preferred but not mandatory.

• 5 to 8+ years of manufacturing, process or industrial engineering experience.

• 3+ years of medical device or IVD manufacturing experience preferred.

• Demonstrated ownership of NPI, validation, technology transfer and customer-facing technical activities.