Software Validation Engineer

Software Validation Engineer

In this organisation you will be a part of the project leader team placed in Tatabánya. The Software Validation Engineer is responsible for supporting projects’ execution whereby cross-border collaboration is required.

Our department is a part of Global Engineering, and overall of Global Operations, which is responsible for manufacturing and end-to-end distribution of medical devices within Ostomy Care, Continence Care and Wound and Skin Care in our factories in Denmark, Hungary, US and China.

Task:

The role of the Software Validation Engineer is to support commissioning projects’ execution with validating software according to Coloplast principles and aligned with international standards.

Your tasks will be:
• Learning software features (PLC or other) of custom built or COTS manufacturing machines from design documentation
• Defining critical functions based on software design in accordance with Coloplast principles
• Participation in the risk analysis of the new machine
• Writing software validation protocols, defining test method for each software function (black box test)
• Checking the software functions defined in the protocol of the production machine
• Documenting test results
• Documentation of non-compliance requirements, participation in investigation and resolution
• Joint work together with other project team member in the projects – internal and external team members
• Preparation of complete validation documentation in English
 

Expectation:

• Relevant college/university (engineering, IT, quality is advantage)
• Fluent English communication both spoken and written
• Good communication skills
• Independent, precise, accurate and on-time work
• Willingness to travel up to 30 to 60 days a year
• Project approach
 

Other:

• Interest in IT, knowledge of PLC is an advantage

What we offer:

• Respectful working environment
• Innovative leadership
• Comfortable working atmosphere with amenities (including in house restaurant & café, free gym)

Pursuing an ambitious growth agenda, Coloplast develops and markets products and services that make life easier for people with intimate healthcare needs. Employing about 12.000 people and with products available in more than 143 countries, we are one of the world´s leading medical device companies. We are constantly growing our business and always looking for new ways to move forward – we explore, learn and look for new ways of doing things.

Coloplast is committed to being an inclusive organization, where people bring their differences to work each day, fulfil their potential and have a strong sense of belonging because – and not despite – of their differences. We therefore encourage all qualified candidates to apply regardless of gender, age, race, nationality, ethnicity, sexual orientation, religious belief or physical ability.

Visit us on Coloplast.com.

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