Mechanical Engineer, Product Development Product Creation · DK - Copenhagen
3Shape
At 3Shape, we are transforming the dental industry with our advanced dental 3D scanners. Join our team as a Mechanical Engineer, where you will contribute to developing products that meet the highest standards of safety, quality, and innovation, enabling dental professionals to provide exceptional care.
Your Role
As a Mechanical Engineer at 3Shape, you will:
- Design and Develop: Create and refine mechanical and electromechanical components for our 3D scanners and medical devices, ensuring compliance with global standards and regulations.
- Ensure Compliance: Work within the frameworks of FDA regulations, ISO 13485, and other medical device standards to ensure our products meet stringent global requirements.
- Leverage Advanced Tools: Use CAD, CAE, and prototyping facilities to conceptualize and verify your designs.
- Collaborate Cross-Functionally: Work closely with international teams in electronics, software, and optics to develop integrated solutions.
- Maintain quality: Develop and document processes in alignment with Quality Management Systems (QMS), ensuring traceability and compliance throughout the product lifecycle.
Your Profile
We are looking for professionals 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 working with complex designs and creating innovative solutions.
Join us in shaping a company culture that makes Monday mornings worth it.
We are an exciting, future-oriented, and international place to work. But most of all, we are a diverse group of over 50 different nationalities who all contribute to a thriving company culture. We partake in social clubs, monthly Friday and various in-team activities as well. If that’s not enough, then add on:
- An attractive healthcare package to keep you fit and well.
- Breakfast every day, and a delicious and healthy lunch cooked by our private chefs.
- Good work/life balance e.g., work from home policy for up to 2 days per week.
- A joint purpose: to enable dentists to provide superior dental care to every patient, every time.
Staying true to our values and D&I efforts, we encourage all relevant applicants to apply, and we ask you NOT to add any photos or sensitive information (age, marital status, nationality) during the application process.
We encourage all relevant applicants to apply. We are committed to celebrating human diversity, and we trust that the best way to reach outstanding business results, is by welcoming diverse people into our community.
About us
3Shape started with a simple idea - to make 3D scanning better. First, we applied it to the hearing industry, then we succeeded in dentistry. Twenty years later, 3Shape has 2,000+ employees globally. With the help of dental professionals and amazing colleagues we’re creating award-winning scanning and CAD/CAM solutions to change dentistry together! Together, we contribute to a better world. Experience the everyday #lifeat3Shape across the globe on LinkedIn.
Department
Product Creation
Role
TRIOS & Scanner
Locations
DK - Copenhagen
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