[Gov Healthcare] Principal Engineer (Quality and Risk Management of Medical Device) Up 7.5K #HJC

Recruit Express Pte Ltd.; Singapore; On-site; SGD 60,000 - 80,000; Full time

Job summary

A leading recruitment agency in Singapore is seeking a professional to assist with the implementation of quality management systems and risk management in medical technology projects. The ideal candidate will have a background in engineering or science, with experience in ISO 13485 and IEC 62304 compliance. Responsibilities include providing guidance on regulatory requirements and managing project tasks. Interested candidates should apply via the provided contact link.

Qualifications

• Minimum 2 years’ experience in quality management systems and risk management processes.
• Experience with ISO 13485 / IEC 62304 audit is highly advantageous.
• Strong verbal and written communication skills.

Responsibilities

• Provide guidance and support for ongoing medical technology projects.
• Ensure compliance with quality and regulatory policies.
• Manage project tasks and coordinate efforts across departments.

Skills

Quality management systems

Risk management processes

Technical writing

Problem-solving skills

Education

Bachelor’s or Master’s Degree in Engineering or Science

Job description

Overview

You will assist to establish processes and work in a team to implement risk management best practices in innovation projects aimed at adoption and commercialisation. You will implement and maintain the office's ISO 13485 and IEC 62304-compliant quality management system processes and procedures across departmental work and projects.

Your technical responsibilities include providing guidance and development support to ongoing medical technology projects. This encompasses validating unmet clinical needs, advising project teams on regulatory, quality and risk requirements, performing risk assessments of proposed solutions with consideration of regulatory requirements, and conducting clinical need filtering and de-risking.

You will ensure compliance with quality, regulatory and organisational policies and systems while supporting required record-keeping and documentation. Managing project tasks includes recommending grants, ensuring timely completion of project milestones for successful grant applications, and meeting KPIs set by the grant agency and manager.

This role combines project coordination, quality management system implementation, risk assessment and technical writing. It is ideally suited for candidates with experience or strong interest in supporting medical device innovations in the healthcare industry.

Responsibilities

• Provide guidance and development support to ongoing medical technology projects, including validating unmet clinical needs, advising on regulatory, quality and risk requirements, performing risk assessments of proposed solutions, and conducting clinical need filtering and de-risking.
• Ensure compliance with quality, regulatory and organisational policies and systems; support required record-keeping and documentation.
• Manage project tasks including recommending grants, ensuring timely completion of project milestones for successful grant applications, and meeting KPIs set by the grant agency and manager.
• Coordinate projects by integrating risk management best practices into innovation efforts and maintaining ISO 13485 and IEC 62304-compliant QMS processes across departments.

Qualifications

• Bachelor’s or Master’s Degree in Engineering or Science with minimum 2 years’ experience in quality management systems, risk management processes, and/or design and development of medical devices
• Experience in risk management processes for medical technology development
• Experience in implementation/maintenance of a quality management system
• Experience in ISO13485 / IEC62304 audit is highly advantageous
• Experience in the software development lifecycle is highly advantageous
• Experience in project coordination, technical project management, and/or technical documentation implementation/maintenance is desirable
• Familiarity with ISO 13485, ISO 14971, IEC 62304, ISO14155, Medical Device Regulatory, Medical Device Standards, Risk Management for Medical Devices
• Strong verbal and written communication skills with proven teamwork abilities
• Strong problem-solving skills and technical writing skills
• Meticulous, detail-oriented, responsible and self-motivated

How to apply

TELE me at @jacechooo or WA me at https://wa.me/[phone] NOW! Interested candidates please submit your resume to [e-mail]

Jace Choo Oi Kei
Personnel EA License No.: R1875164
Recruit Express Pte Ltd (EA Licence No.: 99C4599)