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Materials Engineer

Ambu
3-5 Years
Penang, Malaysia

This job is no longer accepting applications

Job Description

Responsibilities

  • Lead design changes for existing products driven by material obsolescence, supply risk mitigation, dual sourcing, and cost optimization, in alignment with business strategy and regulatory requirements.
  • Plan, coordinate, and drive end-to-end change activities, including scope definition, timeline management, risk identification, and stakeholder alignment across cross-functional teams.
  • Collaborate closely with R&D, Quality, Manufacturing, and Supply Chain to ensure smooth execution of design changes, sample builds, qualification, and implementation activities.
  • Manage technical aspects of sourcing materials, components, tooling, and parts from suppliers; ensure specifications, quality, and regulatory compliance are met.
  • Evaluate and qualify new materials, suppliers, and tooling to support sustaining, dual sourcing, and supply continuity initiatives.
  • Develop, execute, and document test plans and validation strategies; perform root cause analysis for material- or supplier-related failures.
  • Generate technical justifications and risk assessments to optimize qualification approaches, including testing scope and representative sample selection.
  • Identify and drive cost reduction opportunities through material optimization, re-specification, and design improvements.
  • Re-engineer products in accordance with design change procedures to improve cost efficiency while maintaining product quality, reliability, and performance.
  • Support implementation and industrialization activities, including process validation (PCS, IQ, OQ, PQ), sample builds, and production readiness.
  • Troubleshoot material and process-related issues in manufacturing and evaluate alternative process windows when required.
  • Ensure all activities are documented in accordance with quality management system (QMS) and regulatory requirements.
  • Coach and mentor junior Materials Engineers as needed.

Requirements

  • Strong technical/engineering expertise with in-depth knowledge of medical device standards; ISO 13485 knowledge is preferable.
  • Bachelor's degree in Materials engineering, Mechanical Engineering, Biotechnology, Biomedical Engineering, or a related engineering discipline relevant to the medical industry.
  • Minimum 3–5 years of relevant working experience, with a proven track record of achievements in the field.
  • Detail-oriented, organized, capable of delivering high quality work.
  • Enthusiastic about medical devices manufacturing industries.
  • Possess strong analytical & problem-solving skill.
  • Innovative and out of box thinker.
  • Independent, dedicated with a high sense of integrity.
  • Strong initiative and ability to work in self-directed and teamwork environment.
  • Willing to go extra miles to achieve department KPIs, result oriented.
  • Ability to work collaboratively across multi-functional teams.
  • Positive mindset and can-do attitude.

More Info

Job Type:
Permanent Job
Industry:
Other
Function:
Medical Devices
Employment Type:
Full time

About Company

Job ID: 151928765

Last Updated: 08-08-2026 05:58:26 PM
Homejobs in PenangMaterials Engineer

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