Design Engineer - Medical Devices

Basel-Stadt  ‐ Vor Ort
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Beschreibung

We are recruiting for a Design Engineer who will be involved in the design and development of next generation combination devices such as pen injectors, auto-injectors. This is a long-term contract position.

Responsibilities:
  • Lead technical development activities for medical devices used in combination products eg. auto-injector or needle safety devices.
  • Specify requirements of delivery system and device components.
  • Work with third party suppliers to develop the device components and ensure a robust process is followed (specifications, mechanical design, DfM, DfA (Design for Manufacturing & Assembly ), tolerance analysis, risk analysis, testing)
  • You will be working on CAD, Solidworks to create your designs
  • Work with third party suppliers to establish robust manufacturing process and map critical to quality design requirements to manufacturing controls
  • Ensure components are delivered and controlled to the required quality for clinical trials and commercial production.
  • Co-ordinate technical activities with other functions responsible for primary and secondary packaging, human factors engineering, risk management and verification testing.
  • Generate Design Controls documentation while contributing to a high-quality Design History File (DHF) for parenteral delivery injection systems. Author and Reviewer of DHF documents such as Design Input Requirements, Component Specifications, Design Verification Plan and Verification Summary Report. Ensure quality and compliance to applicable regulations of the DHF elements of the assigned projects.
  • Ensure device design development in compliance with the regulations and delivered to a high quality.
  • Root cause analysis of out-of-specification product and develop robust solutions to prevent re-occurrence.


Requirements:
  • Medical Device design and development experience, at least 2 years.
  • Experience using CAD software, Solidworks
  • Excellent technical writing skills (e.g., Design Controls)
  • Good understanding of medical device regulations (FDA 21CFR 820, EU Medical Device Directive)and of combination products (US)
  • Experience in Product Design and Design for Manufacturing
  • Good technical knowledge of needle safety devices or autoinjector development


Kontakt luchele.mendes(at the rate of)mbaswitlzerland.com or call:

Michael Bailey International is acting as an Employment Business in relation to this vacancy.
Start
10/2018
Dauer
10/2020
Von
Michael Bailey Associates
Eingestellt
31.07.2018
Projekt-ID:
1607190
Vertragsart
Freiberuflich
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