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.