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.
- 25 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.
