Assistant Staff Engineer/ Senior Engineer - Verification & Validation

B Braun; George Town; On-site; MYR 150,000 - 200,000; Full time

Job summary

Ein etabliertes Unternehmen im Gesundheitswesen sucht einen Validation Specialist, der alle Aspekte von Ingenieurprojekten und Produktverifizierung verwaltet. In dieser spannenden Rolle werden Sie die Verantwortung für die Planung und Durchführung von Verifizierungs- und Validierungsprojekten übernehmen, während Sie sicherstellen, dass alle Arbeiten den geltenden Vorschriften und Standards entsprechen. Sie bringen mindestens 4 Jahre Erfahrung in der Produktdesign-Verifizierung und -Validierung mit sowie Kenntnisse in SolidWorks oder CAD. Wenn Sie in einem dynamischen, globalen Unternehmen arbeiten möchten, das kontinuierlich in die Verbesserung von Gesundheitslösungen investiert, ist dies die perfekte Gelegenheit für Sie.

Qualifications

• Mindestens 4 Jahre Erfahrung in der Produktdesign-Verifizierung und -Validierung.
• Starke analytische und quantitative Fähigkeiten in der statistischen Analyse.

Responsibilities

• Verwaltung aller Aspekte von Ingenieurprojekten und Produktverifizierung.
• Planung und Durchführung von Verifizierungs- und Validierungsprojekten.

Skills

Produktdesign-Verifizierung

Validierung

Wurzelursachenanalyse

Statistische Analyse

SolidWorks/CAD

ISO 13485

Education

Bachelor in Ingenieurwesen

Tools

SolidWorks

CAD

Job description

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• Manage all aspects of engineering projects and product verification and validation activities, ensuring completion on time and within budget.
• Plan and conduct verification and validation projects using scientific methods, theories, and engineering practices. Design, communicate, and implement execution plans, monitor progress, and resolve problems to keep activities on track.
• Define test specifications, develop test protocols and reports, devise test methods, analyze test results, and prepare reports in compliance with procedures, regulatory requirements, and product requirements. Document deviations, perform investigations, and implement countermeasures as needed.
• Estimate resources and time required for verification and validation activities, continuously monitor progress to ensure targets are met, and prepare regular status reports for the project team.
• Coordinate the transfer of test specifications and methods to cross-functional teams to support design transfer activities. Ensure all work activities comply with applicable regulations and standards.
• Prepare regular reports to communicate the status of projects and tasks to the project team.

What you will bring to the team:

• Minimum Bachelor’s Degree in engineering; preferable in Mechanical, Biochemical, Chemical or Manufacturing.
• At least 4 years of working experience in product design verification and validation, root-cause analysis, and strong analytical and quantitative skills in statistical analysis.
• Experience in SolidWorks/CAD and familiarity with jig and fixture design will be an advantage.
• Experience in product reliability testing, ISO 13485, and product design control according to FDA regulations will be an advantage.

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Your application will include the following questions:

• What's your expected monthly basic salary?
• Which of the following CAD software do you have experience with?
• How many years' experience do you have as a Validation Specialist?
• How many years' experience do you have as a Verification Engineer?

B. Braun Medical Industries Sdn Bhd (BMI) is a subsidiary of B. Braun Melsungen AG, Germany, one of the largest medical devices companies in the world. Established in 1972, B. Braun Medical Industries in Penang is the group’s first manufacturing site in Asia Pacific Region and it is one of the largest B. Braun manufacturing sites for the group outside Europe.

Since its inception in 1972, B. Braun Medical Industries has invested more than MYR4.3 billion in its manufacturing facilities in Malaysia. With more than 7,500 employees, the plant located in Penang is among the largest manufacturers of Medical and Pharmaceutical products not only in Malaysia but also in the region.

Are you looking for a challenge within a dynamic global organisation or a German family business? At B. Braun you can find both. For more than 180 years and counting, B. Braun is amongst the world's top healthcare companies operating in 64 countries, with over 60,000 experts networking their knowledge every day. You can thrive in this strong culture of continuous exchange. Become a part of the B. Braun family and share your expertise. Together we improve healthcare.