Engineer / Senior Engineer

Are you passionate to be in the role as

Engineer / Senior Engineer - R&D Governance (Risk & Usability)?

Do you have experience in Risk and Usability ? If so, this opportunity could be for you Join us at B. Braun, a leader in the medical devices industry, where your skills and experience will be recognized and celebrated. Take the next step in your career with us and help shape the future of healthcare

As a

Engineer / Senior Engineer - R&D Governance (Risk & Usability)

at B. Braun you will play a vital role in…

Your key responsibilities :

• Apply and monitor standards, review and analyze new or amended standards, establish and monitor SOPs, and utilize systems and tools for project management and R&D activities.
• Evaluate and monitor development procedures, SOPs, documentation, and records to ensure compliance with daily practices, and support the creation of SOPs from ideation to production start-up.
• Implement risk management and product risk analysis, focusing on usability engineering and human factors engineering.
• Plan, design, and conduct complex risk management tasks using existing or new methodologies and theories. Conduct risk analysis, including Failure Modes and Effects Analysis (FMEA) and Fault Tree Analysis (FTA). Ensure timely deliverable of risk management outcomes.
• Plan and coordinate formative & summative evaluation. Prepare prerequisites documents, identify supplements, and trace the progress of evaluation with cross-functional teams including design, engineering, regulatory, and quality assurance, to integrate risk management and usability engineering into the product development process..
• Stay updated with the latest industry standards, regulations, and best practices related to risk management and usability engineering. Prepare and maintain comprehensive documentation for regulatory submissions and audits.

What you will bring to the team :

What sets B. Braun apart?

Founded in Germany in 1839, B. Braun is a leading medical technology company with over 66,000 employees in 64 countries. Specializing in infusion therapy, orthopaedics, neurosurgery, anaesthesia, and more, B. Braun develops high-quality products and services that improve global health. In Asia Pacific, B. Braun employs over 16,000 people across 10 production sites and 16 business offices.

Established in 1972, B. Braun Medical Industries in Penang is the regional headquarters for APAC. With more than 7,000 employees, the plant located in Penang is among the largest manufacturers of medical, surgical and pharmaceutical products not only in Malaysia but also in the APAC region. It also houses the Centre of Excellence for Intravenous Access.

What can we offer you?

What's next?

Once you click on the link to Apply, you will be directed to update your personal information and submit your CV. Our Talent Acquisition team will carefully review your application, and if you pass the CV screening you will be invited for the interview. If you stand out and meet our requirements, we will present you with an offer and guide you through our seamless onboarding process. Join us and be part of something extraordinary

We appreciate different perspectives, thoughts, experiences and backgrounds. By strengthening an appreciative, inclusive, respectful and equal working environment, we create a culture in which all our employees feel free to be who they are.

To find out more about our commitment to diversity click here

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B. Braun Medical Ind. Sdn. Bhd. |Sheryn |