An exciting new position has come through for a leading Medical Device Manufacturing company who are recruiting for a Technical Lead. You will have a solid track record of designing and developing the Electronics components for Medical Devices. You will work very closely with your team-member who will be designing embedded software architecture for these next generation medical devices. The devices currently being developed are combination devices such as injectors, autoinjectors, pen-systems, syringes etc.
* Lead technical development activities for electronic components of medical devices used in combination products, e.g. 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.
* Generate Design Controls documentation while contributing to a high-quality Design History File (DHF) for parenteral delivery injection systems.
* 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.
* An ideal candidate would have at least 8 years of experience in electronics medical device development
* Ideally you will have experience focused on medical devices for parenteral administration/ small sized medical devices (pre-filled syringes, injectors).
* Excellent technical writing skills (e.g., Design Controls, DHF documentation)
* Good understanding of medical device regulations (FDA 21CFR 820, EU Medical Device Directive)and of combination products (US) and standards , General understanding of Human Factors Engineering and Risk management
* Ability to work closely with a cross-functional team, you will have strong communication skills, influencing and negotiating skills.
* You will be extremely creative.
Kontact: or call +41 (0) 44 215 2051
Michael Bailey International is acting as an Employment Business in relation to this vacancy.