We are partnering with a leading global contract manufacturer specializing in high-growth industries like medical devices, consumer electronics, and automotive tech. Headquartered in a premier tech hub, they have expanded their footprint into major industrial corridors, providing an excellent platform for talent looking to scale automated manufacturing systems.
Known for robust financial growth and an aggressive engineering roadmap, they offer high-performing professionals substantial career progression, exposure to advanced NPI lifecycles, and a highly collaborative, cross-cultural team environment.
based in Perak.
the job.
New Product Introduction (NPI): Lead the complete rollout of new sterile medical devices, managing equipment selection and formal qualification (IQ/OQ/PQ).
Process Development & Validation: Establish and optimize assembly and packaging methods—including sealing, dispensing, ultrasonic welding, cleaning, and passivation.
Transit & Seal Integrity: Validate finished packaging by testing material compatibility, seal strength, and simulating transport conditions to guarantee sterile product protection.
Tooling & Layout Design: Create and continuously improve production jigs and fixtures using 3D modeling software, while organizing line layouts to maximize OEE.
Quality Compliance & Analysis: Maintain full technical documentation (SOPs, PFMEAs, WBOMs) and direct root-cause investigations into product failures or yield drops.
the experience.
Degree in Mechanical, Automation, Electronics, Biomedical Engineering, or a related discipline.
Minimum 5 years in manufacturing/R&D, with at least 3 years specifically within the medical device space.
Highly proficient in advanced assembly tech, GD&T tolerance stack-up analysis, quality tools (SPC, FMEA), and 3D CAD design.
Well-versed in ISO 13485 standards and DFM principles
