Beschreibung
Senior Development Engineer (Mechanical Engineering)Mission description
For the Power Tools' Product Development team, we are looking for an experienced Development Engineer who will support base business activities in R&D and product lifecycle management.
Power Tools are electromechanical devices used in surgical operations, therefore we are looking for a mechanical engineer with experience in this specific area of medical devices.
Duties and Responsibilities:
- Be responsible for the design and development of instruments, as well as improvements and modifications of existing products.
- Participate in new product development project teams comprised of interdisciplinary
members and who work closely with surgeons, sales and market development managers.
- Collaborate with the technical engineering office, generate product models, concept layouts, complete testing requirements and use CAD software.
- Maintain awareness of surgical, clinical, and technological trends.
- Information exchange and collaboration between internal, local, external and foreign partners is essential. Close cooperation with internal departments, domestic and international authorities as well as the conscientious preparation of the required documents ensures compliance with Medical Device Regulations (EU MDD, US FDA, JP PAL).
Profile:
- Higher degree in mechanical engineering and have had already a previous experience in the design and development of Medical Devices.
- You are self-motivated and take 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.
- Fluent English & German is required.
Technical profile:
- Engineering Experience: min. 5-year experience in development of electromechanical tools, instruments or small machines.
- Min. 3-year experience in the MedTech business.
- Regulations / Standards knowledge:
o ISO 13485
o ISO 14971
o MDD / MDR
o US FDA
- Ability to understand and adhere to complex and interlinked processes
- Ability to write technical documentation fulfilling our process requirements
- Technical Competences:
o Mechanical development
o Sustaining Engineering experience (Product Lifecycle Management)
o Pro-E CAD knowledge
o Good understanding of risk-based development
o Verification testing experience
Michael Bailey International is acting as an Employment Business in relation to this vacancy.