Design Engineer for Advanced Medical Devices

6 hours ago


Copenhagen, Copenhagen, Denmark 3Shape AS Full time

At 3Shape, we are pioneering the development of cutting-edge dental 3D scanners. We seek an experienced Design Engineer to contribute to creating innovative products that meet the highest standards of safety, quality, and innovation, empowering dental professionals to deliver exceptional care.

Your Role

We are looking for a skilled Design Engineer to design and develop mechanical and electromechanical components for our 3D scanners and medical devices, ensuring compliance with global standards and regulations.

  • Component Development: Create and refine mechanical and electromechanical components using CAD, CAE, and prototyping facilities.
  • Compliance Expertise: Ensure our products meet stringent global requirements by working within frameworks like FDA regulations, ISO 13485, and other medical device standards.
  • Cross-Functional Collaboration: Work closely with international teams in electronics, software, and optics to develop integrated solutions.
  • Quality Assurance: Develop and document processes in alignment with Quality Management Systems (QMS), ensuring traceability and compliance throughout the product lifecycle.

Your Profile

We are seeking a professional with:

  • Educational Background: A B.Sc. or higher in Mechanical Engineering, Plastics Engineering, or a related field.
  • Experience: A minimum of 5 years of experience in developing and manufacturing mechanical components, preferably in the medical device industry.
  • Regulatory Expertise: Familiarity with FDA regulations (e.g., 21 CFR 820), ISO 13485, MDR, or similar frameworks.
  • Technical Skills: Proficiency in 3D CAD (e.g., SolidWorks), familiarity with CAE tools, and strong knowledge of materials and manufacturing processes.
  • Attention to Detail: A high focus on ensuring design quality, safety, and adherence to user requirements.
  • Collaborative Approach: Experience in contributing to multidisciplinary and cross-functional groups.
  • Problem-Solving Mindset: Ability to work with complex designs and create innovative solutions.

As a member of our team, you will enjoy:

  • Competitive Salary: $120,000 - $150,000 per year, depending on experience.
  • Benefits Package: An attractive healthcare package, breakfast every day, and a delicious and healthy lunch cooked by our private chefs.
  • Work-Life Balance: A flexible work schedule with up to 2 days of remote work per week.
  • Collaborative Environment: Join our diverse and inclusive team of over 50 nationalities.


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