Beschreibung
For our client in Basel we are looking for an Electronics Medical Device Technical Expert for a 6-month project.
Duration: to (with extension)
Location: Basel
Workload: 90% - 100%
We are looking for a candidate who has:
* 8+ years of experience in electronics device development (with main focus on medical devices)
* Experience generating DHF documentation (design input requirements, technical specifications, design verification, design validation, and design transfer)
. Excellent technical writing skills (eg, Design Controls)
. Good understanding of medical device regulations (FDA 21CFR 820, EU Medical Device Directive) and of combination products (US) and standards
. Fluent English
. General understanding of Human Factors Engineering and Risk management
. General understanding of pharmaceutical development
The perfect candidate will:
. Lead technical development activities for electronic components of medical devices used in combination products, eg auto-injectors, pumps
. Specify requirements (DIR) of electronic components and define component strategy for future component platforms
. Consider power management with an emphasis on ultra-low current and battery optimization for extended shelf-life of products
. Collaborate with mechanical design engineers in the integration of electronic components in the product design
. Collaborate with human factors engineers in the selecting appropriate electronic components for human interface including buttons, displays, speakers
. Collaborate with Embedded software engineers to ensure hardware requirements are met
. Work with third party suppliers for detailed design and development of electronic components and to ensure a robust process is followed (specifications, risk analysis, schematics and PCB layout, testing)
. Planning, executing and reporting on design verification and robustness testing including storage, transport, in-use over defined life-time and misuse cases such as drop and water immersion
. Work with third party suppliers to establish robust manufacturing process of electronic components 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.
. Report in to the Device Project Leader and Delivery System Leader on all technical aspects related to the device development project.
. 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.
For further details please contact Beata Arciszewska:
email: (see below)