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.
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.
- 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
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
- Quality minded
- Service minded
- Good communication skills
- Good teamwork and proactiveness
- Systematical and methodical approach (e.g. structured documenting skills)
- Curious and critical mindset
- 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
About Us
3Shape A/S is a Danish company specializing in the development and marketing of 3D scanners and CAD/CAM software solutions for the use, creation, processing, analysis and management of high quality 3D data.
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 fulfill 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.