Process Specialist with Agile Mindset

You’re in a meeting with the Regulatory Director. She explains the consequences if we do not get the company’s new product approved for the EU market in time. Yesterday, you heard from the QA team that the main barrier is the 2016 adjustments to the ISO 13485 standard - the adjustments must be addressed in the R&D processes. Afterwards, more than 20 R&D project managers need to be trained – and, more importantly, need to agree with the proposed changes.

Oh, and the deadline is in five weeks.

You pass by the coffee machine on your way back to your desk. Nothing ignites the creative juices like a good cup of java made on fresh beans. The word processor comes to life at your command; you dig in and start to write.

Suddenly you look up – hours have passed without notice, you have been totally immersed in your task.  The result is a lean and simple addition to the R&D procedures that will allow the project managers to continue running their agile teams without drowning in paperwork, but it also meets the requirements of the ISO standard.

Above all else, it ensures patient safety. Safety first!

Satisfied you stretch your legs and head to the kitchen for a refill.

Does the above scenario appeal to you?

3Shape has a long-standing track record of successfully combining Agile development with the ever-increasing regulatory demands of the medical device industry. We do this by being innovative in the way we design our processes – instead of just copying the standards verbatim, extra effort is put into creating a system that combines the best of both worlds.

Because we know brilliant products requires both structure and freedom to innovate.

Now, we are looking for a new colleague to join our team, to be the champion of the agile process.

Your profile

  • A strong understanding and passion for Agile principles as championed by SCRUM, KanBan, LEAN, and other philosophies
  • Expert in playing Bingo with standards and industry guidance regulating medical device development, e.g. ISO13485, FDA 21CFR Part 820, ISO 14971, and EN62304
  • Excellent written English
  • A degree in Engineering, Computer Science, Process Optimization, Technical Writing, or similar
  • Perhaps you even have a background in product development from similar companies

We offer

  • An attractive work location in downtown Copenhagen
  • An international atmosphere – we are more than 30 nationalities in our building
  • To be part of Denmark’s most successful medical device company – we’ve grown by more than 33% each year for 15 years straight.
  • Competitive packages to keep you feeling valued
  • A fast-paced, innovative environment with lots of room for career growth
  • Fresh lunch cooked by our resident chef in our new canteen

Please contact thomas.clemen@3shape.com with any questions regarding the position.

If you are interested in this opportunity, apply already today by clicking on “send application” and uploading your motivational cover letter and resume. We will review applications continuously.

Application deadline

asap

Location

Copenhagen

Contacts

Thomas Clemen

Send application

http://www.3shape.com

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.