Senior Manufacturing Engineer

QBOYD SOFTWARE SOLUTIONS; Kuala Lumpur; On-site; MYR 120,000 - 190,000; Full time

Job summary

QBOYD SOFTWARE SOLUTIONS in Kuala Lumpur is seeking an experienced Manufacturing Engineer to design, validate, and scale manufacturing processes for high-volume electronics and medical devices. You will lead process development for fabrication, assembly and test, and ensure supplier adherence to quality standards.

With 10+ years in manufacturing process support, you will drive yield improvements, cost reductions, and NPI gate activities (EVT/DVT/PVT/MP).

Qualifications

• Experience in end-to-end manufacturing for high-volume electronics and/or electro-mechanical medical products.
• Strong knowledge of sub-assembly fabrication, final assembly, FATP, and packaging.
• Experience with EMS contract manufacturers (CM/JDM/ODM/OEM) models.
• Formal training as an ME or MFG ENG with product qualification and process development experience.

Responsibilities

• Lead hardware quality process execution day-to-day.
• Develop and validate fabrication, assembly and test processes for mass production.
• Drive yield improvement, cost reduction and process validation projects.
• Support NPI programs and EVT/DVT/PVT/MP phase gate activities.
• Collaborate with suppliers and EMS to ensure quality conformity.

Skills

Manufacturing engineering

Process optimization

New product introduction

Quality systems

FMEA / CAPA

EMS collaboration

Cross-functional leadership

Documentation & SOPs

Education

Bachelor's or Master's in Engineering

Tools

Google Suite

Slack

Job description

Ensure that our manufacturing processes, fixtures and tools are designed, validated, implemented and maintained for efficient mass production.

Ensure development of fabrication, assembly and test processes and tools for high volume, long-lasting, cost effective and quality-oriented contract manufacturing.

Ensure component and final product suppliers adhere to design, fabrication, assembly and quality specifications and standards.

Ensure day-to-day leadership in coordinating the hardware quality process execution.

Ensure building out a world-class hardware team (operations and product), highly knowledgeable in the end-to-end manufacturing processes and supply chain.

Engage with contract manufacturers and suppliers both remotely and onsite as needed.

WHAT WE'RE LOOKING FOR

Experience working with end-to-end processes producing high-volume, consumer electronics and/or electro-mechanical medical products.

Good technical understanding and experience with sub-assembly fabrication, final assembly & qualification processes including injection molding, metal fabrication, FATP & packaging.

Extensive experience engaging with EMS contract manufacturers within one or more of CM, JDM, ODM and/or OEM models, including a good understanding of differences in roles, responsibilities and behaviors across the various models.

Demonstrated technical training, knowledge and experience as a Manufacturing or Mechanical Engineer taking products from inception to mass production and working closely with component suppliers and EMS final assembly operations.

Proven ability to lead projects and drive yield improvement, cost reduction, process/product validation and process efficiency improvement projects.

Understanding and demonstrated experience contributing to NPI programs and good knowledge of EVT/DVT/PVT/MP phase gate criteria and methodology including disciplines for pFMEA and Process Validation.

Good understanding and practical experience with QMS systems and preferably knowledge and experience with industry standards relative to Class II or III medical products, FDA & ISO 13485 standards.

Formally trained as an ME or MFG ENG and a good understanding and comfort level engaging at a functional level within those disciplines for product qualification, process development, functional test and data management processes & issues.

Some understanding and experience working with embedded systems.

Ability to simplify technical issues and communicate with non-technical team members.

Ability to drive consensus & collaboration within cross-functional teams across complex projects and agendas.

Candidate to be familiar with supplier quality management procedures used in the medical device industry.

Ability to use proper problem solving and analytical tools (eg. 7-QC tool) in driving CAPA.

Flexible, adaptable to a fast-paced industry environment, open-minded and dynamic team player.

Ability to travel in-region as and when required.

Knowledge of Google suite/apps and Slack is recommended.

Knowledge in AI, CAD or SW Programming will be an added advantage.

Self-driven and proven ability to be proactive and provide solutions, even in unfamiliar territory.

Strong written & verbal communication skills in English, Mandarin Chinese and/or Malay is desirable.

Master or Bachelor's Degree in Engineering discipline.

10+ years experience in a manufacturing process support role