Engineer/ Senior Engineer - R&D Governance (Risk & Usability)
You’re an important part of our future. Hopefully, we're also a part of your future! At B. Braun, we protect and improve the health of people worldwide. You support this vision, bringing expertise and sharing innovation, efficiency and sustainability as values. That’s why we would like to keep developing our company with you. Keeping your future in mind, we’re making a joint contribution to health care worldwide, with trust, transparency and appreciation. That's Sharing Expertise.
Are you passionate to be in the role as Engineer/ Senior Engineer - R&D Governance (Risk & Usability)? Do you have experience in Rish 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 projects using existing or new methods and theories, and manage all aspects of R&D projects to ensure timely and budget-compliant completion.
- Identify, develop, and gather necessary resources for R&D projects, prepare engineering standards, designs, work specifications, project schedules, budgets, and forecasts, and select materials, equipment, project staff, and external contractors.
- Estimate costs, resources, and time required for R&D projects, monitor activities, allocate resources, assign tasks to meet targets, devise methods, calculate and analyze results, prepare detailed reports with recommendations, develop and maintain technical expertise, and coach and mentor less experienced staff.
What you will bring to the team:
- Bachelor of Science and Engineering. At least 2 years of experience in a related field or in Quality Engineering/Management within the medical device industry.
- Experiences in methodological compliance for Risk & Usability Methods within Medical Device Development & Lifecycle-Management.
- Knowledge of ISO 14971:2019, IEC 62366-1:2020, FDA Guideline for Human Factors 2016, medical device regulations and product risk management.
- Outstanding written skill in English language, good communication and persuasive skills.
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?
- Retirement benefit scheme
- Long service award
- Medical insurance
- Training and development programs
- Education assistance program
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 | [email protected]