Technical Lead - Electronics for Medical Device

Vertragsart:
Vor Ort
Start:
01/10/2018
Dauer:
01/10/2019
Von:
Michael Bailey Associates - Munich
Ort:
Basel
Eingestellt:
31.07.2018
Land:
flag_no Schweiz
Projekt-ID:
1607100

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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.

Responsibilities

  • 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.
  • 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.

Requirements

  • 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 (eg, 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.

Contact or call.

Michael Bailey International is acting as an Employment Business in relation to this vacancy.