Description
Injection Device Expert with excellent technical writing skills wanted for our Basel based client in the pharmaceutical sector.Your experience/skills:
- 8+ years' experience in device development of parenteral delivery systems with main focus on medical devices for parenteral administration
- Profound experience in Product Design and Design for Manufacturing, ideally in generating DHF documentation
- Excellent technical writing skills like Design Controls coupled with good technical knowledge of primary containers development and needle safety devices or autoinjector development
- Good understanding of medical device regulations, such as FDA 21CFR 820 and EU Medical Device Directive as well as of combination products (US)
- General understanding of Human Factors Engineering, Risk Management plus clinical trial processes and requirements
- Languages: fluent English both written and spoken
Your tasks:
- Leading technical development activities for medical devices used in combination products and specifying requirements of delivery system and device components
- Collaborating with third party suppliers to develop device components as well as establishing and ensuring a robust manufacturing process
- Ensuring components are delivered and controlled to required compliance with regulations and quality for clinical trials and commercial production
- Coordinating technical activities with other functions responsible for primary and secondary packaging, human factors engineering, risk management and verification testing
- Generating Design Controls documentation while contributing, authoring and reviewing a high-quality Design History File for parenteral delivery injection systems
- Root cause analysis of out-of-specification product and developing robust solutions to prevent re-occurrence
Start:
Duration: 6MM+
Location: Basel, Switzerland
Ref.Nr.: BH13249
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