Description
We have an exciting contract opportunity for an experienced Development Engineer who has previous exposure working in the design and development of Orthopaedic devices. You will have a great opportunity to work with a Global Leader in this field and contribute to the development of world class instruments, implants, and surgical tools.Responsibilities:
- Responsible for the design and development of new Orthopaedic implants and instruments.
- Complete and support on Design History File documentation considering New Product Development Process, e.g. Verification and Validation Methods, Reports, Risk Management documentation.
- Collaborate with the mechanical test lab to complete testing requirements.
- Collaborate with technical engineering office to support on generating product models and use CAD software (Creo).
- Experience in FEA / ANSYS would be ideal.
- Execute early stage prototype testing and document/summarize results following GDP standards.
- Coordinate execution of orders with involved shared service departments.
- Information exchange and collaboration between internal, local, external and foreign partners is essential.
- Close cooperation with internal departments, as well as the conscientious preparation of the required documents ensures compliance with Medical Device Regulations (EU MDD, US FDA, JP PAL).
Requirements:
- For this position we are looking for a team player with strong initiative.
- You will have earned a higher degree in engineering and have practical experience in a regulated industry, ideally in a Medical Device (Orthopedic/ Trauma) industry.
- You are self-motivated and take strong responsibility in your projects.
- You are a creative problem-solver with excellent communication skills and strong leadership ability.
- You should have a keen interest in the interrelations between medicine and technology and a strong desire to work in a global company.
- Ability to communicate in both spoken and written English is required.
Kontakt: Luchele Mendes
Michael Bailey International is acting as an Employment Business in relation to this vacancy.