Project Engineer (Medical Device)

BARRINGTON JAMES LIMITED Singapore Branch; Singapore; On-site; SGD 60,000 - 80,000; Full time

Job summary

A leading medical device company in Singapore is seeking a Project Engineer to support new product introductions and cross-functional project execution. The ideal candidate will have a Bachelor's Degree in Engineering and 2-5 years of experience in a regulated environment. Key responsibilities include leading engineering projects, maintaining compliance with ISO and FDA standards, and driving continuous improvement initiatives. Strong communication and analytical skills are essential for success in this role.

Qualifications

• 2–5 years of experience in a medical device, pharmaceutical, semiconductor, or regulated manufacturing environment.
• Good knowledge of ISO 13485, GMP, and FDA QSR compliance.
• Hands-on experience in equipment qualification and process validation.

Responsibilities

• Lead and support engineering projects including NPI and equipment qualification.
• Coordinate cross-functional teams to ensure timely execution of project deliverables.
• Prepare project plans, timelines, and technical documentation.
• Drive continuous improvement initiatives to enhance manufacturing capability.

Skills

Project coordination

Root cause analysis

Analytical skills

Communication skills

Education

Bachelor’s Degree in Mechanical, Electrical, Biomedical, or related Engineering field

Tools

Technical documentation tools

Job description

Project Engineer (Medical Device)

Location: Singapore

Employment Type: Full-Time

About the Role

The Project Engineer plays a key role in supporting new product introductions (NPI), sustaining engineering activities, process improvements, and cross-functional project execution within a regulated medical device manufacturing environment. This role ensures projects are delivered on time, within scope, and in compliance with ISO 13485 and FDA 21 CFR Part 820 requirements.

Key Responsibilities

• Lead and support engineering projects including NPI, equipment qualification, process validation, and design transfer activities.
• Coordinate cross-functional teams (QA, RA, Manufacturing, R&D, Supply Chain) to ensure timely execution of project deliverables.
• Prepare project plans, timelines, FMEAs, risk assessments, and technical documentation.
• Execute IQ/OQ/PQ activities and ensure compliance to validation and regulatory standards.
• Drive continuous improvement initiatives to enhance manufacturing capability, product quality, and cost efficiency.
• Troubleshoot production issues, conduct root cause analysis, and implement corrective & preventive actions (CAPA).
• Maintain project documentation according to ISO 13485/9001 requirements.
• Manage vendor interactions for equipment procurement, qualification, and process integration.
• Support audits, change control activities, and engineering documentation updates (SOPs, WIs, protocols, reports).

Requirements

• Bachelor’s Degree in Mechanical, Electrical, Biomedical, or related Engineering field.
• 2–5 years of experience in a medical device, pharmaceutical, semiconductor, or regulated manufacturing environment.
• Good knowledge of ISO 13485, GMP, FDA QSR, validation principles, and risk management (ISO 14971).
• Hands-on experience in equipment qualification, process validation, and project coordination.
• Strong analytical skills with experience in root cause analysis (8D, Fishbone, 5 Whys).
• Proficiency in technical documentation, project tracking, and engineering tools.
• Strong communication skills and ability to collaborate across departments.
• Ability to manage multiple projects and meet timeline commitments.

Preferred (Nice to Have)

• Experience with cleanroom operations, automation, or high-precision assembly processes.
• Exposure to NPI, design transfer, or manufacturing scale-up.
• Knowledge in Lean, Six Sigma, or related continuous improvement methodologies.