About the role
Amber Implants is looking for a Product Design Engineer. In this role, you are responsible for design, development and experimental verification and validation of innovative medical products (orthopedic implants) in compliance with the Design Control procedures. You posses and apply knowledge of medical device engineering principles, practices, and procedures. Additionally, you are responsible for maintaining compliance with industry guidelines, regulatory requirements and maintaining Design History Files. In addition, you make sure that the manufacturability of the parts is guaranteed by interacting with suppliers. During this process you will have an internal coach to guide you through the activities in the company.
What you will do
- Optimizing the required manufacturing steps for the medical devices and creation of technical documents required for manufacturing;
- Designing and developing medical devices according to ISO 13485;
- Designing quality inspection and verification test setups and rigs;
- Support Regulatory submissions, such as 510(k) and CE mark, from a technical standpoint;
- Investigating state of the art in the spinal field and supporting patent submission;
- Other duties as assigned by Executive Management;
- A Master degree in Industrial, Mechanical or Biomedical Engineering (or similar majors);
- Prior experience with product development in the medical devices, and preferably with spinal or orthopedic implants under ISO 13485;
- Experience in design of parts using traditional machining and additive manufacturing;
- Strong skills in utilizing CAD software preferably Fusion 360 or SolidWorks;
- Eye for detail, pragmatic and result-oriented;
- Reliable energetic personality that delivers what is promised;
- Ability to work independently as well as part of a team. Open for feedback;
- Ability to build long term relationships with suppliers within the Amber Implants network;
- Strong analytical skills and excellent command in English, both written and spoken. Dutch and German is nice to have.
- The opportunity to improve patient care and deliver high-quality products;
- The opportunity to work in a young, ambitious, rapidly-growing company with an international market;
- Attractive salary;
- An exciting, diverse work environment where new challenges are faced every day;
- Attractive work environment (including discounted access to GYM and other facilities of the WTC building, the Hauge and different canteens with warm food and good coffee);
- 25 days of paid time off;
- Fun company atmosphere with Friday afternoon drink and group activities.
About the company
Amber Implants is a fast-growing medical technology company located in The Hague, The Netherlands, with a focus on the development of a new implant for treatment of painful spinal fracture which affects millions of patients globally every year. Amber Implants has developed the first cementless device in the world to treat vertebral fractures. The company received a breakthrough device designation by the FDA and plan to start the clinical trials in 2022. Amber Implants has a flat organization structure composed of a young, ambitious and rapidly expanding team, located in WTC, the Hague, with a modern atmosphere and an informal culture. We are a company that recognizes your efforts, listens to your suggestions, gives you feedback to improve and congratulates you on your achievements, making it a pleasant work
environment. The vacancy is for a full-time position (36-40 hours per week). We are flexible in our work times, but it is prefered to be at the office when working.
To apply, please send you motivation letter together with you full CV and motivation letter to firstname.lastname@example.org
For more information you can always contact us.
Attention: **STRICTLY NO AGENCIES PLEASE!**