Sr Process / Manufacturing Engineer (IVD / Medical Device)

Jabil Circuit Sdn Bhd; Singapore; On-site; SGD 90,000 - 125,000; Full time

Job summary

Jabil Circuit Sdn Bhd in Singapore seeks a Senior Process / Manufacturing Engineer (IVD / Medical Device) to lead end-to-end manufacturing architecture, capacity planning and technology transfer for new and existing products.

You will drive process validation, equipment qualification, automation initiatives and support regulatory readiness during ISO, FDA and customer audits, while coaching engineers and coordinating cross-functional problem solving.

Qualifications

• 5–8+ years in manufacturing or industrial engineering.
• 3+ years in medical device or IVD manufacturing preferred.
• Bachelor’s in Engineering; advanced degree welcomed but not required.

Responsibilities

• Define end-to-end manufacturing architecture, production scaling and capacity planning.
• Lead technology transfer, readiness and process standardization for new or transferred products.
• Develop automation strategy and evaluate advanced manufacturing technologies.
• Lead complex root cause analysis and apply SPC/DOE and process simulation.
• Prepare for ISO, FDA readiness reviews and regulatory inspections.
• Coach engineers and technicians; support cross-functional problem solving and RFQ work.

Skills

Root cause analysis

SPC/DOE

Process validation

Automation strategy

Cross-functional leadership

Education

Bachelor Degree in Engineering

Advanced degree preferred

Experience in IVD/Medical Device manufacturing

Job description

Sr Process / Manufacturing Engineer (IVD / Medical Device)

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.
• 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.