Ambu A/S

Materials Engineer

Ambu A/S  •  Pulau Pinang, MY (Onsite)  •  1 hour ago
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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.
Ambu A/S

About Ambu A/S

Innovations that make a difference

Ever since 1937, Ambu has been rethinking medical solutions to save lives and improve patient care. Millions of patients and healthcare professionals worldwide depend on the efficiency, safety and performance of our single-use endoscopy, anaesthesia and patient monitoring solutions.

In the past, we provided a way to maintain or restore breathing in any environment with the world’s first self-inflating resuscitator, the Ambu® Bag™, which is still in use today. More recently, we responded to a need for an endoscopy solution that is always available. The result? Ambu® aScope™, the world’s first sterile, single-use flexible endoscope.

Today, we continue to collaborate with leading medical experts to deliver innovations that make a real difference to healthcare professionals and their patients.

At our headquarters in Copenhagen, Denmark, and around the world in Europe, North America and the Asia Pacific, 5,000+ team members keep Ambu moving forward.

For more information, please visit www.ambu.com

Industry
Manufacturing & Production
Company Size
1,001-5,000 employees
Headquarters
Ballerup, DK
Year Founded
1937
Website
ambu.com
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