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.
