**STRICTLY NO AGENCIES PLEASE!**

About the company

Amber Implants is a medical technology company based in Delft, The Netherlands. Founded in 2016, Amber Implants focuses on the design and manufacturing of innovative orthopedic implants using additive manufacturing production methods. The company develops innovative spinal cage implants which will be sold in the US and Europe.

Job description:

The Senior Product Development Engineer is responsible for the design and development of new and improved product (spinal implant and instrument) in compliance to the Design Control procedures. The Senior Product Development Engineer is responsible to execute the design and development activities throughout the product development lifecycle. In addition, he/she provides technical guidance and coaching for the engineering team. Must possess and apply knowledge of medical device engineering principles, practices, and procedures. The Senior Product Development Engineer is also responsible for maintaining compliance to industry guidelines, GMP, regulatory requirements, and maintaining Design History Files.

Position responsibilities:

  • Lead activities associated with the design and development of new product, specialty product, and sustaining work using GMP, the company’s design control procedure, and quality management system.
  • Responsible for complex new product development projects. Lead a cross-functional team throughout the project lifecycle, from concept to launch. Ownership of the project plan, project management, and key deliverables. Participate in the budget planning cycle for the projects.
  • Participate actively with Marketing and Sales to define customer needs. Engage surgeons and key opinion leaders throughout the conceptualization and development phases. Lead development sessions and actively participate in cadaver labs with surgeons to obtain critical project input.
  • Conceptualize new design of spinal implant and instrument to meet customer needs and by incorporating human factors/usability engineering in the design process. Work closely with designer/drafter to generate models and prints using GD&T (Geometrical Dimensioning and Tolerance). Collaborate with manufacturing and external vendors to review prints and apply DFM (Design for Manufacturability) principles.
  • Evaluate the performance and feasibility of early concepts in cadaveric lab and by conducting design of experiments – such as mechanical performance evaluation and Sawbone simulation.
  • Participate in risk management activities (e.g. dFMEA, pFMEA) and lead design activities such as Design Input, Design Output, Design Verification, Design Validation, and Design Transfer. Responsible to perform the Design Reviews and create the Design History Files documentation. Serve as technical leader within the product development team.
  • Support Regulatory submissions, such as 510(k) and CE mark, from a technical standpoint.
  • Lead the cleaning, packaging, and sterilization validation activities. Manage the development of instrument trays and BOM.
  • Develop novel innovations for inclusion in IP Portfolio. Support in the launch of NPD projects with Freedom to Operate – FTO. Perform assessment of competitive landscape in support of projects, development pipeline, and competitive library/matrix.
  • Other duties as assigned by Executive Management.

Qualification:

  • A minimum of a Bachelor’s degree in Mechanical Engineering or Biomedical Engineering with mechanics’ focus is required.
  • A Master’s degree is desired.
  • A minimum of 5 years of new product development in the medical field is required.
  • A minimum 2 years of experience of spinal or orthopedic implants development and a demonstrated background in developing creative solutions to solve design problems is highly preferred.
  • Experience in identifying user needs (VOC), design principles, material selection, ability to verify and validate design concepts, and understand design failure modes is required.
  • Demonstrated understanding of different types of manufacturing, mechanisms, materials, proper tolerancing, drafting standards, and GD&T are required.
  • A successful track record of leading and influencing others without authority, participating on cross-functional teams and solid negotiating skills to bring products from concept to launch is required.
  • Experience utilizing computer aided design (CAD) to develop a product is required.
  • A successful track record of leading and influencing others without authority, participating on cross-functional teams and solid negotiating skills to bring products from concept to launch is required.
  • Experience with FDA Medical Device guidelines and medical device directive (93/42/EEC) or medical device regulation (May 5th 2017) is preferred.
  • Must demonstrate a strong initiative and follow through in executing project responsibilities, overcoming obstacles and balancing multiple priorities effectively through strong technical and/or project leadership experience.
  • The ability to review and critically assess patents and other forms of intellectual property is preferred.
  • This position is based in Delft, the Netherlands and may require up to 10% domestic and international travel.

Are you interested and the person we are looking for?

Then, please send your CV and motivation letter and CV to info@amberimplants.com. You also see the vacant in our LinkedIn

If you have any questions regarding this position, please contact m.ahmadi@amberimplants.com.

**STRICTLY NO AGENCIES PLEASE!**