Beschreibung
Medical Device Technical Expert wanted for our Basel based client in the pharmaceutical sector.Your experience/skills:
- 8+ years' experience in software development with main focus on medical devices for parenteral administration and generating DHF documentation, including designing input requirements, technical specifications, design verification, validation, and transfer.
- Excellent technical writing skills, ideally in Design Controls
- Good understanding of medical device regulations, such as FDA 21CFR 820 and EU Medical Device Directive coupled with combination products (US) and standards
- General understanding of Pharmaceutical Development, Human Factors Engineering and Risk management
- Good organisation and communication skills
- Languages: fluent English both written and spoken
Your tasks:
- Specifying requirements of software components and defining architecture for future platforms
- Collaborating with human factors engineers and electronics experts to ensure appropriate hardware defined for software requirements
- Ensuring data security and integrity as well as fail-safe operation through architectural design and real time error checking, errors as well as device design development in compliance with the regulations and delivered to a high quality
- Managing suppliers in detailed software design, coding and documentation with consideration of medical device classification
- Applying security protocols for wireless communication as well as planning and reviewing the verification and validation of the software to ensure safe and secure operation
- Generating Design Controls documentation, authoring and reviewing documents and ensuring the quality and compliance to applicable regulations
Start:
Duration: 6MM+
Location: Basel, Switzerland
Ref.Nr.: BH13220
Does this sound like an interesting and challenging opportunity to you? Then take the next step by sending us your CV as a Word document and a contact telephone number.
Due to work permit restrictions we can unfortunately only consider applications from EU or Swiss citizens as well as current work-permit holders for Switzerland.
Going the extra mile…
New to Switzerland? In case of successful placement, we support you with:
- All administrative questions
- Finding an apartment
- Health - and social insurance
- Work permit and much more