Location
singapore
Job Type
Full-time
Posted
June 10, 2026
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 activiti...