Medical Device Technical Expert/Device Development (Pharma) (Ref.Nr.:

MEDICAL DEVICE TECHNICAL EXPERT/DEVICE DEVELOPMENT (PHARMA) (REF.NR.: HS2262)

BRINE SA has been placing top IT specialists at well-known customers for over 30 years. In doing so, we focus on performance, competence, experience and partnerships.

ROLE DESCRIPTION:

An 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 and would have experience generating DHF documentation, including but not limited to design input requirements, technical specifications, design verification, design validation, and design transfer.

MAJOR TASKS:

- Run and lead technical development activities for medical devices eg auto injector, safety syringes.
- Generate Design Controls documentation while contributing to a high-quality Design History File (DHF) for parenteral delivery injection systems. Author and Reviewer of DHF documents. Ensure quality and compliance to applicable regulations of the DHF elements of the assigned projects
- Ensure device design development in compliance with the regulations and delivered at a high quality
- Consult on the development of medical devices and combination products

REQUIREMENTS:

- Excellent technical writing skills (eg, Design Controls)
- Good understanding of medical device regulations (FDA 21CFR 820, EU Medical Device Directive) and of combination products (US)
- Experience in Product Design and Design for Manufacturing
- Good technical knowledge of primary containers & auto injector development
- General understanding of Human Factors Engineering and Risk management
- General understanding of clinical trial processes and requirements
- General understanding of pharmaceutical development
- Support DRA to prepare Medical Device/Combination Product pre-registration documents and answer health authority questions.

To learn more about this opportunity please send your CV ASAP in Word format to BRINE SA.

WORK LOCATION: Basel

START: Sept 2017

DURATION: Feb 2018

WORKLOAD: 100%

SALARY: Local Market rate according to experience

PERMIT: EU permits

LANGUAGE: English

REF. NR.: HS2262

BRINE SA has been providing its IT- and SAP specialists for short-, mid- and long-term projects in Switzerland since 1985, with customers primarily active in the following market sectors:

Financial services sector, especially banks and insurance companies

Pharmaceutical industry

Government and services sectors

BRINE SA is a stable, financially independent, Swiss enterprise with its head office in Zurich. Our services cover the entire IT spectrum, as well as interfaces to the various business sectors, and range from management- and IT-consulting through to software development and project implementation.

IT - RESOURCES

We offer our top consultants, computer Profi's and SAP experts to our customers as external specialists for limited assignments and as well for permanent positions. BRINE SA is especially distinguished by its renowned characteristic strengths:

Short reaction time - rapid selection and supply of consultant's CVs, with skills matched to customer requirements.

Quality - we take quality very seriously, both for internal and external-facing processes, thereby convincing many customers to maintain a long-standing business relationship with BRINE SA

Coaching - BRINE SA coaches and supports its consultants throughout the entire duration of the customer assignment.

BRINE SA is ISO 9001:2008 certified since 2014.