Validation Engineer, R&D Support Centre

Over the past 10 years, 3Shape has successfully launched several revolutionary optical 3D scanner products, serving the audiological and dental restoration industries. 3Shape Dental Lab scanners enable efficient digital workflows by scanning dental impressions and gypsum models, in order to facilitate CAD design of dental restorations. CAD design of dental restorations.

The TRIOS scanners enable high-definition, digital workflows directly in the dental clinic, and are disrupting the traditional dental workflows by eliminating the need for physical impressions of patient teeth. A new and innovative Dental X-ray scanner product, 3Shape X1, will complete the 3Shape scanner product range by providing the necessary data for advanced dental implant planning.

To support further growth, and in order to advance production methods and efficiency, we are establishing an R&D Support Center at our production site in Szczecin, Poland. The center will become a hub for processes like design transfer and production optimization, and among others feature a full-scale milling center for prototypes. The center will grow in proportion to the 3Shape group, and be responsible for the advance of production processes and tools required to maintain our position as industry-leading 3D scanning systems.

 

Job Description

As the Validation Engineer, you will be evaluating equipment and procedures used in production of our scanners. You will be ensuring the systems are running according to necessary specifications and operating within regulations to ensure the production of highest quality products.

 

In particular, your area of responsibility will cover steps from defining validation processes/procedures, through execution and finally documentation of the results.

Key part of your work will be to:

  • Plan, execute and document validation of processes and tools including work with Master Validation Plan
  • Perform and coordinate validations within processes including IQ (Installation Qualification), OQ (Operational Qualification), PQ (Performance Qualification)
  • Verify validation results in cooperation with R&D departments
  • Prepare and archive validation reports, supervise updates for documentation
  • Assess the validation needs for tools and processes
  • Suggest and implement agreed improvement solutions
  • Close cooperation with Q&PE and R&D departaments

 

Candidate profile

 The successful candidate should possess solid technical competence – have M.Sc. in engineering and present experience within:

  • Validation in the area of Medical devices and Development tools
  • Knowledge of FDA requirements will be an advantage
  • Preparation of documentation for validation process according to FDA requirements
  • Risk assessment
  • Technical documentation and reports
  • Excellent English skills

Other expected skills:

  • Quality minded
  • Service minded
  • Good communication skills
  • Good teamwork and proactiveness
  • Systematical and methodical approach (e.g. structured documenting skills)
  • Curious and critical mindset

 

What we offer

  • An attractive work environment in novel production facility with an informal atmosphere, among best in class colleagues
  • Competitive employment terms and benefits
  • Stable employment conditions (contract of employment)
  • Personal growth and development through continuous learning
  • Company events

 

Please attach your Curriculum Vitae and add consent for processing personal data.

 

Please add consent for processing personal data:

“I agree to process my personal data for current recruitment procedure in accordance with article 6 item 1 lit. "a" of the Regulation of the European Parliament and of the Council (EU) 2016/679 of 27th of April 2016 on the protection of individuals with regard to the processing of personal data and on the free movement of such data and repealing Directive 95/46 / EC (General Data Protection Regulation).”

If you would like that your CV is placed in 3Shape recruitment data base for future recruitment, please add second clause in your CV: “I agree to process my personal data for future recruitment procedures as well”.

In accordance with provisions of GDPR please be informed that the data controller in this case is 3Shape Poland Sp. z o. o. with headquarters in Szczecin 70-033, at Zapadła 8d, but your application may be proceeded within the 3Shape Group. Your personal data will be used only for purpose related to the recruitment procedures and will be kept in our database for a period of 12 months. More information about proceeding of your personal data by 3Shape you may find here or contacting local HR Department.

Please be informed, in case of interview in our company, that the 3Shape Poland Sp. z o. o. uses closed circuit television (CCTV) images to provide a safe and secure environment for employees and for visitors to the 3Shape Poland Sp. z o. o. business premises as well as to protect the 3Shape Poland Sp. z o. o. property and assets. The CCTV system may be used to investigate security incidents in order to secure evidence, should such incidents occur. All footage gathered is stored no longer than 30 days. The images that are filmed are recorded centrally and held in a secure location.

 

 


About Us

3Shape is changing dentistry together with dental professionals across the world by developing innovations that provide superior dental care for patients. Our portfolio of 3D scanners and CAD/CAM software solutions for the dental industry includes the multiple award-winning 3Shape TRIOS intraoral scanner, the upcoming 3Shape X1 CBCT scanner, and market leading scanning and design software solutions for dental labs.
Two graduate students founded 3Shape in Denmark’s capital in the year 2000. Today, 3Shape has over 1,500 employees serving customers in over 100 countries from an ever-growing number of 3Shape offices around the world. 3Shape’s products and innovations continue to challenge traditional methods, enabling dental professionals to treat more patients more effectively. www.3shape.com

Working at 3Shape

Become part of an international success, financially as well as product wise. As an employee, you have plenty of room to both make a difference and fulfil personal ambitions in a very knowledge intensive and challenging environment.

3Shape Technology

Through the relentless drive for new digital innovation by 3Shape, we claim to be the most extensive and versatile CAD/CAM system on the market.

3Shape - a Global Company

3Shape is headquartered in Copenhagen, with development teams in Denmark as well as in the Ukraine and with a production site in Poland. 3Shape is a global company with presence in Europe, Asia and the Americas.

Our People

Employing and developing the right people is an important key to 3Shape's success. We want to be the best within our business, an ambition which has created a true fighting spirit throughout the company - with lots of commitment and courage, and a professional attitude towards business.