Job Description

Description

:

• Perform system level testing and verification on design changes (with R&D approval). Implement tests that validate the quality and the functionality of product. In collaboration with R&D, lead team in system verification and validation testing design and execution to ensure product performance meets requirements.
• Collaborate with R&D on new product launch and transfer to manufacturing.
• Provide technical support to Mfg. site and work on Product sustaining and troubleshoot manufacturing issues to support Mfg. Engineering.
• Update/maintain design specification and technical documentation of on-market products.
• Design Integration testing and roadmap in collaboration with Project Management to ensure successful adherence to time management and key milestones. Ensure smooth transition from NPI to Production.
• In collaboration with R&D, develop design input requirements and design specifications consistent with company guidelines, regulations, and user needs and manage the subsystem extrapolations and implementations of those requirements where appropriate. Drive alignment between subsystem plans and design input requirements for design changes.
• Support cross functional teams and work as a system engineering subject matter expert to evaluate, troubleshoot, and suggest improvements for on market products.
• Lead the FMEA and risk analysis for any design changes.
• Support CM in managing supplier change notification whenever there is EOL/ obsolescence and coordinate with LCM, Supply Assurance and Commodity teams to ensure minimum disruption to the supply chain.
• Collaborate with suppliers to address technical problems, root cause of quality issues and recommend timely corrective action is taken to secure continuity of supply.

Requirement

• Min. degree in Engineering (Electrical/Electronics). Master\'s degree is preferred.
• Min. 8 years systems engineering experience leading and supporting multidisciplinary teams, external development partners, and manufacturing partners.
• Proven ability to lead teams.
• Strong background in system design and validation of complex medical devices (programmable electromechanical systems). IVD experience preferred.
• Experience working in FDA regulated environment with knowledge of 21 CFR 820 Part 11 is required.
• Experience with HW and SW interfaces, as well as the HW and SW architecture is required.
• Experience with using lifecycle management tools for requirement management and traceability (e.g. JAMA) is required.

Interested candidate, please send CV to alexgoh@recruitexpress.com.sg

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Alex Goh Hock Leong

(CEI.No: R1763413 l Recruit Express Pte Ltd (Healthcare & Life Science) | 99C4599)

Industry

Healthcare / Pharmaceutical / Life Science / Medical Device
Production / Manufacturing

Specialization

Engineering
Healthcare - Pharmaceutical / Life Science / Medical Device / Clinical Research / Regulatory Affairs
Production / Manufacturing

Location

East

Employment Type

Permanent

Salary

S$6,001 to S$10,000 / mth

Interested candidate, please send CV to alexgoh@recruitexpress.com.sg

\xe2\x9e\x96

Alex Goh Hock Leong

(CEI.No: R1763413 l Recruit Express Pte Ltd (Healthcare & Life Science) | 99C4599)

*All information will be treated with strictest confidence. We regret that only short-listed applicants will be notified.

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