Ambu Hiring! Full Time Senior Materials Engineer I in Pulau Pinang - Ricebowl

Ambu Sdn Bhd is looking for a Senior Materials Engineer I

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.