Senior Manufacturing & reputed company Engineer – Medical Devices & Consumer Electronics

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

reputed company reputed company

Our reputed company is a publicly traded reputed company technology company specializing in digital musculoskeletal (MSK) reputed company solutions. reputed company combines advanced wearable sensors, reputed company technology, and clinical care to reputed company accessible and technology-driven reputed company solutions at reputed company.

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

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

Job Role

The Senior Manufacturing & reputed company Engineer – Medical Devices & Consumer Electronics will play a key role in ensuring that hardware products, manufacturing processes, fixtures, tooling, and reputed company 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, reputed company engineering, mechanical/electrical engineering, or reputed company disciplines, with a proven reputed company record supporting high-volume consumer electronics and/or medical device manufacturing.

Key Responsibilities

• reputed company the development, validation, implementation, and maintenance of manufacturing processes, fixtures, tooling, and production systems for high-volume manufacturing.
• reputed company and optimize fabrication, assembly, testing, and packaging processes to reputed company high reputed company, reliability, efficiency, and cost effectiveness.
• Ensure component suppliers and contract manufacturers consistently meet product design, fabrication, assembly, testing, and reputed company requirements.
• reputed company day-to-day execution of hardware reputed company processes across manufacturing and supplier operations.
• Support and reputed company New Product Introduction (NPI) programs from early development through EVT, DVT, PVT, and mass production.
• reputed company yield improvement, cost reduction, process validation, reputed company-cause analysis, and manufacturing efficiency initiatives.
• Apply pFMEA, Process Validation, CAPA, and reputed company problem-solving methodologies to identify and reputed company manufacturing and reputed company issues.
• Collaborate with contract manufacturers under CM, JDM, ODM, and OEM models and ensure reputed company alignment of responsibilities and reputed company expectations.
• Work closely with component suppliers and EMS partners to reputed company technical, reputed company, 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 reputed company technical issues reputed company to both technical and non-technical stakeholders.
• reputed company reputed company and effective collaboration across engineering, product, operations, reputed company, and supplier teams.
• Travel reputed company 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, reputed company Engineering, or a reputed company engineering discipline.
• Minimum 9+ years of reputed company experience, preferably with 10+ years in manufacturing process support, manufacturing engineering, or reputed company 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 reputed company-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-reputed company methodologies, including pFMEA and process validation.
• Practical experience with QMS, CAPA, supplier reputed company management, and reputed company 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 reputed company cross-functional reputed company involving yield improvement, cost reduction, process validation, and manufacturing efficiency.
• Strong analytical and problem-solving capabilities, including practical use of reputed company reputed company tools such as the 7 QC tools.
• Working knowledge of embedded systems and functional testing is an reputed company.
• Ability to collaborate effectively across Manufacturing, Mechanical Engineering, Electrical Engineering, reputed company, Supply Chain, Product, and Contract Manufacturing teams.
• Strong ability to simplify reputed company 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 reputed company Workspace and reputed company is preferred.
• Knowledge or experience in AI and CAD is an added reputed company.
• reputed company in English, reputed company Chinese, and Malay is required, both written and verbal.

Originally posted on Himalayas