Location
singapore
Job Type
Full-time
Posted
June 16, 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 activities and ensure compliance to validation and regulatory standards. Drive continuous improvement initiatives to enhance ma...
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 ma...