Job description for Senior Manufacturing & Quality Engineer (Medical Device) (#845) at PT Talenta Eksekutif Asia
The candidate must be based in Johor Bahru, Kuala Lumpur, or Penang, Malaysia. This is primarily a remote position with regional travel and occasional visits to manufacturing facilities, suppliers, and manufacturing partners.
- Client Overview
- Our client is a publicly traded healthcare technology company specializing in digital musculoskeletal healthcare solutions.
The organization develops technology driven healthcare products combining wearable sensors, connected hardware, computer vision, and clinical care.
The company works with enterprise clients, healthcare providers, health plans, and strategic partners across international markets.
As the company continues to expand its hardware and medical device operations, it is strengthening its manufacturing, quality, supplier management, and product validation capabilities to support high volume production.
Job Role
The Senior Manufacturing and Quality Engineer will be responsible for ensuring that hardware products and manufacturing processes are developed, validated, and maintained for efficient and reliable mass production.
The role will work closely with manufacturing partners, component suppliers, engineering teams, product teams, quality teams, and internal operations stakeholders throughout the product lifecycle.
The ideal candidate is an experienced manufacturing or quality engineering professional with strong hands on experience in high volume consumer electronics and medical device manufacturing.
- Key Responsibilities
- Lead the development and implementation of manufacturing processes and production systems.
- Develop and improve fabrication, assembly, testing, and packaging processes.
- Ensure suppliers and manufacturing partners meet product and quality requirements.
- Lead hardware quality activities across manufacturing and supplier operations.
- Support new product introduction programs from product development through mass production.
- Lead yield improvement, cost reduction, process validation, root cause analysis, and manufacturing efficiency initiatives.
- Apply structured quality and problem solving methods to identify and resolve manufacturing issues.
- Manage technical and quality collaboration with manufacturing partners.
- Work closely with component suppliers and electronic manufacturing partners.
- Support manufacturing readiness and production improvement programs.
- Conduct remote and on site engagement with suppliers and manufacturing partners.
- Communicate technical and quality issues clearly to internal and external stakeholders.
- Collaborate with engineering, product, operations, quality, supply chain, and manufacturing teams.
- Travel regionally when required to support suppliers and manufacturing projects.
- Candidate Requirements
Bachelor’s or Master’s Degree in Manufacturing Engineering, Mechanical Engineering, Electrical Engineering, Quality Engineering, or a related engineering discipline.
- Extensive professional experience in manufacturing engineering, manufacturing process support, or quality engineering.
- Proven experience supporting hardware products from product development through mass production.
- Strong experience in consumer electronics or electro mechanical medical device manufacturing.
Hands on knowledge of injection molding, metal fabrication, electronic components, surface mount technology, batteries, final assembly, testing, and packaging.
- Experience working with electronic manufacturing and contract manufacturing partners.
- Strong understanding of product validation and manufacturing readiness processes.
- Experience with process risk analysis, process validation, corrective action, preventive action, and quality improvement.
- Experience with quality management systems and supplier quality management.
- Knowledge of medical device quality and regulatory requirements.
- Strong analytical and problem solving skills.
- Experience leading cross functional manufacturing and quality projects.
- Strong communication and stakeholder management skills.
- Ability to communicate complex technical issues clearly to non technical stakeholders.
- Self driven, proactive, adaptable, and comfortable working in a fast paced environment.
- Willingness to travel regionally when required.
- Knowledge of workplace productivity and communication tools is preferred.
- Knowledge of artificial intelligence and computer aided design is an advantage.
- Fluent in English, Mandarin Chinese, and Malay, both written and spoken.
- Job Code: #845