Senior Test Engineer (IVD / Medical Device)

JABIL CIRCUIT (SINGAPORE) PTE. LTD.; Singapore; On-site; SGD 120,000 - 180,000; Full time

Job summary

Jabil Circuit (Singapore) PTE. LTD. seeks a senior test engineer to lead test engineering for medical devices and IVD systems, directing NPI, validation strategies, and audit readiness. You will partner with Manufacturing, Quality, Process, IT, and customers to ensure robust test solutions.

The role requires a strong background in test architecture, automated platforms, and regulatory knowledge (FDA/ISO 13485). You will mentor junior engineers and drive continuous improvement.

Qualifications

• Bachelor's degree in engineering required.
• 5–8+ years of test engineering experience.
• 3+ years of medical device or IVD analyzer exposure preferred.
• Ownership of NPI, validation programs, and customer transfer; audit support.

Responsibilities

• Lead test engineering activities for medical devices and IVD systems.
• Define test strategy, approve validation plans and automation architecture.
• Coach junior engineers and establish testing standards and training plans.
• Support regulatory audits (FDA, ISO 13485, MDSAP) and CAPA actions.
• Lead customer technical reviews and interface with manufacturing, quality, and IT teams.
• Drive cross-functional problem solving to improve quality and efficiency.

Skills

Test leadership

Cross-functional collaboration

Regulatory knowledge

Analytical thinking

Customer interaction

Education

Bachelor's degree in Engineering

Tools

LabVIEW

NI TestStand

Python

C#

Database integration

MES integration

Job description

OUR COMPANY

• 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 RESPONSIBILITIES

Technical Leadership

• Lead, coach, and guide junior test engineers.
• 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.
• Advanced skills in LabVIEW, NI TestStand, Python, C#, database integration, MES integration, and automated reporting preferred.
• 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.

KEY REQUIREMENTS

• Bachelor's degree in Engineering; advanced degree is preferred but not mandatory.
• 5 to 8+ years of test engineering experience.
• 3+ years of medical device or IVD analyzer experience preferred.
• Demonstrated ownership of NPI, validation programs, customer transfer, and audit support.