Test Engineer III (IVD / Medical Device)
Leads test engineering for medical devices and IVD systems, defining validation strategies, test architectures, and regulatory compliance while coaching junior engineers and driving cross-functional problem-solving.
- Compensation
- Not disclosed
- Location
- Singapore
- Work setup
- Not specified
- Seniority
- Not specified
- Employment
- Not specified
- Experience
- Not specified
- Category
- Qa
- Posted
Skills
Must have
- Expert knowledge of test architecture, system-level diagnostics, failure analysis, design for testability, automated test platforms, and production data analytics
- Strong knowledge of ISO 13485, FDA 21 CFR Part 820, IQ/OQ/PQ, process validation, risk management, ISO 14971, CAPA, and design/process change control
- Bachelor Degree in Engineering; 5 to 8+ years of test engineering experience
Nice to have
- Advanced skills in LabVIEW, NI TestStand, Python, C#, database integration, MES integration, and automated reporting
- 3+ years of medical device or IVD analyzer experience
Full description
At Jabil (NYSE: JBL), we are proud to be a trusted partner for the world's 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
Acts as the technical leader for test engineering activities related to medical devices and IVD systems. Leads NPI, test technology development, validation strategy, customer engagement, audit readiness, and continuous improvement initiatives.
Key ResponsibilitiesTechnical Leadership
- Lead, coach, and guide Test Engineer I and II resources.
- Establish test engineering standards, best practices, and training plans.
- Review technical solutions, validation plans, and test readiness deliverables.
- Drive cross-functional problem solving with Manufacturing, Quality, Process, IT, and Customer teams.
Test Architecture Ownership
- Define overall test strategy for assigned medical or IVD programs.
- Approve test station design, measurement approach, validation strategy, and automation architecture.
- Evaluate and implement new test technologies for quality, efficiency, and compliance improvement.
IVD Subject Matter Expertise
- Serve as SME for IVD analyzer testing such as hematology, urinalysis, immunoassay, molecular diagnostics, optical detection, fluidics, motion control, and robotic subsystems.
- Lead complex failure analysis on integrated instrument systems.
- Assess technical gaps during customer transfer and manufacturing readiness reviews.
Regulatory and Audit Leadership
- Lead FDA, ISO 13485, MDSAP, and customer audit support related to test engineering.
- Approve validation deliverables and ensure inspection readiness.
- Review risk assessments, change controls, CAPA actions, and validation impact assessments.
Customer Interface
- Act as technical escalation point for assigned customer programs.
- Lead customer technical reviews and present validation or test performance results.
- Support RFQ responses, transfer planning, and manufacturing readiness strategy.
Technical Requirements
- Expert knowledge of test architecture, system-level diagnostics, failure analysis, design for testability, automated test platforms, and production data analytics.