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Product Development Engineer

About the role

The Product Development Engineer is responsible for the design and development of innovative medical products (orthopedic implants) in compliance with the Design Control procedures. The candidate possesses and applies knowledge of medical device engineering principles, practices, and procedures. The Product Development Engineer is also responsible for maintaining compliance with industry guidelines, regulatory requirements, and maintaining Design History Files. In addition, the candidate makes sure of manufacturability of the parts by interacting with suppliers.

During this process the Product Development Engineer will have an internal coach to have a quick learning process for the activities in the company.

Responsibilities

  • Design and development of medical devices according to specifications and regulatory requirements.
  • Conducting research and analysis to understand user needs, technical requirements, and market trends.
  • Communicate with R&D engineers and end-users (medical professionals) to translate all the needs and demands into the design of the device
  • Creating detailed design plans, including schematics, drawings, and specifications.
  • Design and develop appropriate manufacturing plans for medical devices
  • Design and development of R&D accessories and manufacturing jigs and fixtures
  • Support the quality assurance team in the technical documentation required for transfer of the product
  • Address technical issues arising during product manufacturing by actively participating in and communicating with cross-functional teams and suppliers to resolve them effectively.
  • Support to resolve any technical issues for manufacturing a designed component
  • Conducting a search of filed patents and commercial products to ensure freedom to operate for the designs of the products of the company.

You have

  • A Master degree in Design, Industrial, Mechanical or Biomedical Engineering (or similar majors).
  • Minimum 2 year 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 are nice to have

About the company

Amber Implants is a fast-growing clinical-stage medical device start-up operating in the orthopedics and trauma field. We have created a novel spinal implant (VCFix Spinal System) for treating traumatic vertebral fractures in a minimally invasive approach. We have completed all preclinical testing of this product and started in-human clinical trials. Amber Implants has a flat organizational 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). The employees are required to work from the office for this position.

To apply, please send you motivation letter together with you full CV and motivation letter to info@amberimplants.com
For more information you can always contact us.