Senior Manufacturing & Quality Engineer – Medical Devices & Consumer Electronics

PT Talenta Eksekutif Asia; George Town; Remote; MYR 180,000 - 240,000; Full time

Job summary

PT Talenta Eksekutif Asia seeks a Senior Manufacturing & Quality Engineer for Medical Devices & Consumer Electronics in Malaysia. You will lead manufacturing processes, QA systems, and production readiness for hardware, collaborating with contract manufacturers and suppliers across the product lifecycle.

The role requires 9+ years in manufacturing or quality engineering, with hands-on experience in injection molding, SMT, and medical device quality, plus ISO 13485/FDA knowledge.

Qualifications

• Bachelor's or Master's degree in a relevant engineering discipline.
• 9+ years of professional experience in manufacturing process support, manufacturing engineering, or quality engineering.
• Experience taking hardware products from development through NPI to mass production in high-volume environments.
• Experience in consumer electronics and/or electro-mechanical medical devices.
• Knowledge of injection molding, SMT, testing, and packaging processes.

Responsibilities

• Lead development, validation, and maintenance of manufacturing processes, fixtures, tooling, and production systems.
• Drive NPI programs from early development through EVT, DVT, PVT, to mass production.
• Ensure suppliers and contract manufacturers meet design, fabrication, assembly, testing, and quality requirements.
• Lead quality processes across manufacturing and supplier operations.
• Apply pFMEA, CAPA, and structured problem solving to resolve issues.
• Collaborate with CM, JDM, ODM, and OEM partners and align quality expectations.
• Travel regionally to support suppliers and production sites.

Skills

Manufacturing Engineering

Quality Engineering

Electronics manufacturing

Cross-functional collaboration

Problem solving

English, Mandarin, Malay fluency

Education

Bachelor's or Master's Degree in Manufacturing/Mechanical/Electrical Engineering or related

Job description

This role is open to candidates based in Johor Bahru, Kuala Lumpur, or Penang, Malaysia. The position is remote with regional travel as required.

Client Overview

Our client is a publicly traded healthcare technology company specializing in digital musculoskeletal (MSK) healthcare solutions. The company combines advanced wearable sensors, computer vision technology, and clinical care to deliver accessible and technology-driven healthcare solutions at scale.

With a strong presence across the healthcare technology ecosystem, the organization works with enterprise clients, health plans, healthcare providers, and strategic partners to improve patient outcomes while reducing healthcare costs. Its technology portfolio includes connected hardware and digital health solutions that require robust manufacturing, quality, and supply chain processes.

As the company continues to scale its hardware and medical device operations, it is seeking an experienced Manufacturing & Quality Engineer to strengthen manufacturing processes, supplier quality, product validation, and production readiness across its hardware ecosystem.

Job Role

The Senior Manufacturing & Quality Engineer – Medical Devices & Consumer Electronics will play a key role in ensuring that hardware products, manufacturing processes, fixtures, tooling, and quality systems are designed, validated, and maintained for efficient and reliable mass production.

The role will work closely with contract manufacturers, component suppliers, engineering teams, and internal product and operations stakeholders throughout the product lifecycle—from new product introduction (NPI) through mass production.

The ideal candidate brings strong hands-on experience in manufacturing engineering, quality engineering, mechanical/electrical engineering, or related disciplines, with a proven track record supporting high-volume consumer electronics and/or medical device manufacturing.

Key Responsibilities

• Lead the development, validation, implementation, and maintenance of manufacturing processes, fixtures, tooling, and production systems for high-volume manufacturing.
• Develop and optimize fabrication, assembly, testing, and packaging processes to achieve high quality, reliability, efficiency, and cost effectiveness.
• Ensure component suppliers and contract manufacturers consistently meet product design, fabrication, assembly, testing, and quality requirements.
• Lead day-to-day execution of hardware quality processes across manufacturing and supplier operations.
• Support and drive New Product Introduction (NPI) programs from early development through EVT, DVT, PVT, and mass production.
• Lead yield improvement, cost reduction, process validation, root-cause analysis, and manufacturing efficiency initiatives.
• Apply pFMEA, Process Validation, CAPA, and structured problem-solving methodologies to identify and resolve manufacturing and quality issues.
• Collaborate with contract manufacturers under CM, JDM, ODM, and OEM models and ensure clear alignment of responsibilities and quality expectations.
• Work closely with component suppliers and EMS partners to resolve technical, quality, and production issues.
• Support the development of a world-class hardware operations and product organization with strong end-to-end manufacturing and supply chain capabilities.
• Engage with contract manufacturers and suppliers remotely and onsite as required.
• Communicate complex technical issues clearly to both technical and non-technical stakeholders.
• Drive consensus and effective collaboration across engineering, product, operations, quality, and supplier teams.
• Travel within the region as required to support suppliers, manufacturing sites, and project activities.

Candidate Requirements

• Bachelor's or Master's Degree in Manufacturing Engineering, Mechanical Engineering, Electrical Engineering, Quality Engineering, or a related engineering discipline.
• Minimum 9+ years of professional experience, preferably with 10+ years in manufacturing process support, manufacturing engineering, or quality engineering roles.
• Proven experience taking hardware products from product development through NPI and mass production in high-volume manufacturing environments.
• Strong experience in consumer electronics and/or electro-mechanical medical device manufacturing.
• Hands-on knowledge of manufacturing and qualification processes including injection molding, metal fabrication, electronic components, SMT, batteries, FATP, and packaging.
• Extensive experience working with EMS contract manufacturers under CM, JDM, ODM, and/or OEM models.
• Strong understanding of EVT, DVT, PVT, and Mass Production phase-gate methodologies, including pFMEA and process validation.
• Practical experience with QMS, CAPA, supplier quality management, and quality compliance for medical devices, preferably Class II or Class III products.
• Knowledge of relevant medical device standards and regulatory requirements, including FDA and ISO 13485.
• Proven ability to lead cross-functional projects involving yield improvement, cost reduction, process validation, and manufacturing efficiency.
• Strong analytical and problem-solving capabilities, including practical use of structured quality tools such as the 7 QC tools.
• Working knowledge of embedded systems and functional testing is an advantage.
• Ability to collaborate effectively across Manufacturing, Mechanical Engineering, Electrical Engineering, Quality, Supply Chain, Product, and Contract Manufacturing teams.
• Strong ability to simplify complex technical issues and communicate them effectively to non-technical stakeholders.
• Self-driven, proactive, adaptable, and comfortable working in a fast-paced and dynamic environment.
• Willingness and ability to travel regionally as required.
• Proficiency with Google Workspace and Slack is preferred.
• Knowledge or experience in AI and CAD is an added advantage.
• Fluency in English, Mandarin Chinese, and Malay is required, both written and verbal.