Medical Device Technical Expert

Harvey Nash is looking for a Medical Device Technical Expert for a 5 + month project in Switzerland.

You are responsible for

- Generating Design Controls documentation while contributing to a high-quality Design History File (DHF) for parenteral delivery injection systems; Authoring and Reviewing of DHF documents; ensuring quality and compliance to applicable regulations of the DHF elements of the assigned projects
- Ensuring device design development in compliance with the regulations and delivered at a high quality
- Consulting on the development of medical devices and combination products
- Supporting DRA to prepare Medical Device/Combination Product pre-registration documents and answering health authority questions.

Requirements

- Excellent technical writing skills (eg, Design Controls)
- Prior experience and good technical knowledge of autoinjector development
- Very good understanding of medical device regulations (FDA 21CFR 820, EU Medical Device Directive)and of combination products (US)
- Good technical knowledge of primary containers development
- Experience in Product Design and Design for Manufacturing
- Excellent written and verbal communication skills
- Proactive in obtaining the required information to progress deliverables according to project plan
- General understanding of Human Factors Engineering and Risk management
- General understanding of clinical trial processes and requirements
- General understanding of pharmaceutical development
- Ideal candidate would have at least 8 years of experience in device development of parenteral delivery systems, eg, drug/device combination products with main focus on medical devices for parenteral administration, specifically auto injectors.
- The ideal candidate would have experience generating DHF documentation, including but not limited to design input requirements, technical specifications, design verification, design validation, and design transfer.

Are you available immediately, have experience working within a Life Science company? Please send your complete CV (Word documents preferred) to (see below) For further details feel free to call me. I am looking forward to receiving your application.