Project Engineer

TALENTS RECRUITER PRIVATE LIMITED; Singapore; On-site; SGD 50,000 - 70,000; Full time

Job summary

A leading recruitment firm in Singapore is looking for a Project Engineer to manage the assembly processes of medical devices, ensuring compliance with regulatory standards. The ideal candidate will have a diploma in engineering, at least 2 years of relevant experience, strong understanding of medical device regulations, and excellent communication skills. This role offers immediate start for qualified candidates.

Qualifications

• Minimum 2 years of relevant working experience.
• Able to start work immediately or on short notice.

Responsibilities

• Plan, coordinate, and oversee the assembly processes of medical devices.
• Lead or support IQ/OQ/PQ activities.
• Develop and maintain engineering documentation.

Skills

Strong understanding of Medical device regulations and standards

Strong technical skills

Good communication and interpersonal skills

Education

Diploma in Engineering or equivalent

Job description

Job Responsibilities:

• Manage project schedule: To plan, coordinate, and oversee the assembly processes of medical devices orequipment, ensuring that production meets design specifications, regulatory standards ISO 13485(Medical Devices QMS) and FDA 21 CFR Part 820(QSR) and project deadlines.
• Lead or support IQ/OQ/PQ (Installation Qualification, Operational Qualification, and PerformanceQualification) activities.
• Develop and maintain engineering documentation, including procedures, processes and quality plan, drawings, and specifications
• Ensure work performed within desired quality and stipulated schedule.
• Ensure customer’s specification and requirements understood and executed as to provide good engineeringsolutions
• Communicating with customers, interpreting their needs and requirements.

Job Requirement :

• Diploma in Engineering or equivalent
• 2 years of relevant working experience
• Strong understanding of Medical device regulations and standards
• Strong technical skills
• Good communication and interpersonal skills
• Able to start work immediate or short notice