Product Validation Engineer

5 days ago


Bayan Lepas, Penang, Malaysia B. Braun Melsungen AG Full time

About Us

B. Braun Melsungen AG is a dynamic family-owned company that actively promotes constructive exchanges between colleagues, customers, and partners. We are committed to improving people's lives in the long term through innovation, efficiency, and sustainability.

What We Offer

We provide interesting, varied tasks and excellent opportunities for advancement, along with an attractive salary with extensive benefits. Our employees enjoy a positive and supportive work environment that fosters growth and development.

Job Description

The Technical Verification Specialist will play a critical role in ensuring the quality and reliability of our products by managing all aspects of engineering projects and product verification activities. This includes planning and conducting verification projects, developing and implementing execution plans, and defining test specifications and protocols.

Responsibilities

  • Manage project timelines, resources, and budgets to ensure successful project delivery.
  • Develop and implement execution plans for completing verification activities, monitor progress, and take action to resolve problems.
  • Define test specifications, develop test protocols & reports, devise test methods, analyze test results, and prepare reports in compliance with regulatory requirements and product specifications.
  • Ensure accurate documentation of deviations, investigations, and countermeasures as required.
  • Coordinate and facilitate the transfer of test specifications and test methods to cross-functional teams as needed to support design transfer activities.

Requirements

  • Minimum Bachelor's Degree in engineering; preferable in Mechanical, Biochemical, Chemical, or Manufacturing.
  • At least 3 years of working experience in product design verification and validation.
  • Experience in Solidworks/CAD and familiarity with jigs and fixtures is an advantage.
  • Experience in conducting test method validation and root cause analysis.
  • Strong analytical and quantitative skills in statistical analysis.
  • Experience in product reliability testing, ISO13485, and product design control according to FDA is an advantage.

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