RecruitPedia Hiring! Full Time Senior Manufacturing Engineer (Medical Device) - upto $6,000 in Southwest (Singapore) - Ricebowl

Our client is one of the leading players in the medical devices manufacturing sector. Due to their current expansion plan, they are looking for a multiple headcounts of Senior Manufacturing Engineer to join their team, in hopes of developing the current high performing team. They are located in the East area.

Job Responsibilities:

• Collaborate with R&D, Quality, Regulatory, Supply Chain and Operations teams to support product development, process improvement and regulatory compliance.
• Lead the transfer of new products from engineering development into manufacturing and ensure production readiness.
• Provide DFM/DFA input during product development to improve manufacturability, reliability, performance and cost.
• Develop, document and optimise manufacturing workflows, assembly processes and work instructions for new products.
• Design and develop fixtures, jigs, tooling, test systems and other equipment required for manufacturing operations.
• Define equipment requirements and coordinate the procurement, installation, qualification and commissioning of manufacturing equipment.
• Establish and validate production test methods and critical process checks to ensure product quality and performance.
• Plan and execute process qualification and validation activities, including IQ, OQ and PQ, to ensure consistent production performance.
• Develop and maintain process FMEAs, control plans and risk mitigation strategies to identify and reduce manufacturing risks.
• Troubleshoot manufacturing issues, lead root-cause investigations and implement process improvements while providing technical guidance to engineers and production teams.
• Prepare and maintain manufacturing documentation, validation reports and quality records within a regulated product development environment.
• Ensure manufacturing activities follow applicable medical device quality systems, design controls, production controls and regulatory requirements, together with other assigned engineering duties.
• Perform any ad-hoc duties as assigned.

Requirements:

• Minimum Degree in Mechanical/Manufacturing Engineering, or a related engineering discipline.
• Minimum 6 years of relevant experience in Manufacturing Engineering.
• Familiar with new product development, product introduction, process validaton or design transfer.
• Strong understanding of DFM/DFA, process capability, manufacturing risk assessment and continuous improvement.
• Skills in IQ/OQ/PQ, PFMEA, control plans, work instructions and manufacturing validation documentation would be advantageous.
• Familiarity with ISO 13485, ISO 14971, FDA 21 CFR 820 and medical device design/production controls.

Interested candidates who wish to apply for the advertised position, please click APPLY NOW or email an updated copy of your resume/cv.

We regret that only shortlisted candidate will be notified.

Email: *************

Recruitpedia Pte. Ltd.

EA License No. 19C9682

EA Reg. No. R23115553 (Lai Hor Yan)