AMK Technology Hiring! Full Time Suppler Development Engineer - Medical Devices in Pulau Pinang - Ricebowl

Hiring: Supplier Development / Supplier Engineer – Medical Devices

Location: Penang, Malaysia

Contract: 6 + 6 months

Working Hours: 8:00 AM – 5:00 PM MYT

Education: Bachelor’s Degree in Mechanical or Biomedical Engineering

Experience: Minimum 3 years of experience in the medical device industry – MUST HAVE

Key Mandatory Requirement

We are looking for candidates with strong Supplier Development / Supplier Engineering experience, particularly in managing manufacturing activities with vendors.

Candidates must be able to:

• Review engineering drawings, specifications, and manufacturing processes

• Work closely with suppliers/vendors to manage manufacturing requirements

• Demonstrate thorough knowledge of GD&T (Geometric Dimensioning & Tolerancing)

• Read and interpret manufacturing drawings and specifications

• Understand manufacturing processes and supplier capabilities

️ Drawing creation is NOT mandatory. Experience in creating engineering drawings is considered a good-to-have skill.

Key Responsibilities

• Support the Supplier Engineering team in delivering quality-driven, cost-effective products that meet customer requirements

• Develop and qualify high-complexity medical devices

• Collaborate with R&D, Manufacturing, Supply Management, Quality, Operations, Marketing, and Regulatory teams

• Manage testing activities to verify products against internal and external requirements

• Support supplier development and manufacturing activities

• Train and mentor team members in specialised technical areas

• Identify and implement innovative solutions to technical challenges

• Ensure compliance with safety policies and procedures

Technical Skills

• Strong mechanical engineering fundamentals

• Knowledge of medical device development and manufacturing

• Knowledge of human anatomy, physiology, surgical procedures, and surgical instrumentation

• Experience with component design, prototyping, development, and qualification

• Strong understanding of GD&T and engineering/manufacturing drawings

• Experience with tolerance stack-up analysis

• Knowledge of metals, plastics, and manufacturing processes

• Experience with 3D CAD / SolidWorks is preferred

• Hands-on experience with rapid prototyping and prototype assembly

• Knowledge of test method development and experiment execution

• Knowledge of Gage R&R, BIAS, and Design of Experiments (DOE) is desirable

• Strong MS Excel and statistical/data analysis skills

• Knowledge of Statistical Process Control (SPC) and Six Sigma / DFSS

• Familiarity with medical device regulations and technical standards

• Strong technical report writing, communication, and presentation skills

Ideal Candidate

• The ideal candidate combines medical device industry experience + supplier development experience + strong GD&T and manufacturing drawing knowledge and can effectively work with vendors to ensure products are manufactured according to engineering specifications.