Full Time Supplier Development Engineer - Medical Devices Jobs, in AMK Technology Pulau Pinang - Maukerja

Supplier Engineer – Medical Devices

Shift Timing: 8:00 AM – 5:00 PM MYT

Experience: Minimum 3 years of relevant experience in the medical device industry

Languages: English mandatory

Role Overview

We are looking for a Supplier Engineer to join the Supplier Engineering team and support the development, qualification, and manufacturing of high-complexity medical devices.

The role will work closely with suppliers and cross-functional teams to ensure products are manufactured according to approved engineering drawings, specifications, quality requirements, and customer expectations.

The ideal candidate must have hands-on supplier development experience, with strong knowledge of GD&T and the ability to read and review engineering/manufacturing drawings, specifications, and manufacturing processes.

Key Responsibilities

• Lead and support supplier development activities to ensure suppliers can manufacture components and products according to engineering drawings, specifications, quality requirements, and agreed timelines.
• Review and interpret engineering drawings, product specifications, tolerances, and manufacturing requirements with suppliers.
• Apply strong knowledge of Geometric Dimensioning & Tolerancing (GD&T) to assess manufacturability and supplier output.
• Work with suppliers to identify and resolve manufacturing, quality, process, and technical issues.
• Evaluate supplier manufacturing processes and recommend improvements to achieve quality, cost, and delivery objectives.
• Collaborate with R&D, Manufacturing, Supply Management, Quality, Operations, Marketing, and Regulatory teams throughout product development and qualification.
• Support the development and qualification of high-complexity medical device components and products.
• Collaborate with internal teams and suppliers to develop appropriate test methods and verification activities to ensure products meet internal and external customer requirements.
• Support prototype development, manufacturing trials, process evaluation, and product qualification activities.
• Conduct technical reviews and provide engineering recommendations based on drawings, specifications, manufacturing processes, and test results.
• Support supplier quality and process improvement initiatives.
• Analyze engineering and manufacturing data and apply appropriate statistical methods to identify trends and technical issues.
• Prepare technical reports, documentation, and presentations for internal and external stakeholders.
• Train and mentor team members in relevant technical and supplier engineering areas.
• Ensure compliance with applicable medical device regulations, technical standards, safety policies, and company procedures.
• Continuously develop technical and professional skills through relevant training and educational programs.

Mandatory Requirements

• Bachelor’s degree in Mechanical Engineering, Biomedical Engineering, or a related engineering discipline.
• Minimum 3 years of professional experience in the medical device industry – mandatory.
• Hands-on supplier development experience – mandatory.
• Proven experience working directly with suppliers on manufacturing, technical requirements, quality, and process issues.
• Strong ability to read and review engineering/manufacturing drawings and specifications – mandatory.
• Thorough knowledge of GD&T – mandatory.
• Ability to understand and evaluate manufacturing processes and manufacturability.
• Experience reviewing supplier output against engineering drawings, specifications, tolerances, and quality requirements.
• Strong understanding of mechanical engineering fundamentals.
• Knowledge of metals, plastics, and manufacturing processes.
• Understanding of the medical device industry and relevant technical standards/regulations.
• Strong communication and stakeholder management skills.
• Strong technical report writing and presentation skills.
• Good working knowledge of Microsoft Excel and data analysis.

Good-to-Have Skills

• Experience creating engineering/manufacturing drawings.
• Proficiency in 3D CAD design and modelling, preferably SolidWorks.
• Experience with design, prototyping, component development, and product qualification.
• Experience with rapid prototyping and hands-on prototype assembly.
• Machine shop experience.
• Experience with tolerance stack-up analysis.
• Knowledge of Gage R&R, BIAS, and Design of Experiments (DOE).
• Knowledge of Statistical Process Control (SPC) and Six Sigma / DFSS.
• Experience with medical device surgical instruments, surgical procedures, or relevant human anatomy and physiology.
• Experience with statistical/data analysis software.

Key Competencies

• Supplier Development
• Engineering Drawing & Specification Review
• GD&T
• Manufacturing Process Understanding
• Supplier Technical Management
• Medical Device Development
• Product Qualification & Validation
• Root Cause Analysis & Problem Solving
• Quality & Process Improvement
• Statistical/Data Analysis
• Cross-functional Collaboration
• Technical Communication

Working Hours

8:00 AM – 5:00 PM MYT