System product engineer / scientist R&D (f/m/d)

System product engineer / scientist R&D (f/m/d) – Verification/ German / analytic/ English /HP ALM

Projekt:
For our client in the Roche Rotkreuz based in Rotkreuz we are looking for a System product engineer / scientist R&D (f/m/d)

Background:

Blood gas & electrolyte (BGE) analysis is used in critical point-of-care settings where time and quality matter. CPS R&D BGE is responsible for development of new and improved BGE analysis systems and life cycle maintenance of existing BGE products. Within BGE R&D, System Integration is where everything comes together: a team of dedicated scientists, engineers and lab technicians ensure that hardware and software fit together with sensor and reagent technologies to form a robust and reliable BGE analysis system.

The System Development and Integration BGE Department is looking for a new team member to work in our cross-functional product care team, which ensures the market success of our complex diagnostics systems, consisting of fluidics, software, instrument, sensors and reagents.

The Department is looking for an experienced technical expert (engineer or scientist, m/f/d) in e.g. biomedical/system engineering, physics, biotechnology or related fields who works in a structured manner and who is familiar with technical aspects of analytical systems. The candidate should have previous experience with IVD. A successful candidate can operate and contribute to defined regulatory processes. With a systems thinking mindset, the complexity and scope of the overall product can be understood, but the person possesses the capability and interest to understand and discuss the technical details..

Tasks & Responsibilities
* Design product improvements and perform hands-on analysis and error-evaluation testing of the systems along with the management of system level documentation in the form of configuration, requirements, and risk management.
* Go-to person for technical product design, testing and troubleshooting, key contributor to product and technical requirements and configuration management, a key contributor to product risk management, an expert for customer complaint 3rd level support, a supporter of manufacturing teams in case of product release issues
* Responsible for maintaining and updating product specifications of analytical systems, e.g. sample throughput, measuring time, sample volumes, calibrations, environmental parameters, compatibility of consumables etc.
* Maintain system level documentation, e.g. product requirement documents, product risk analysis, test reports, traceability, etc

Must Haves:
* University degree or comparable engineering or life science education, with experience in the field of medical diagnostics
* At least 5 years of experience in development of complex systems comprising requirements, verification, and on-market support
* Background in medical device development IVD with knowledge of applicable norms and standards
* Experienced in writing and maintaining system level documents for analytical systems
* Networks and partners well with various experts in R&D, regulatory and quality
* Fluent English

Nice to Haves
* Previous Roche experience
* Experienced with HP ALM or similar life cycle management software
* IVD development experience and knowledge of international regulations
* German speaking & writing
* Obstinate personality who sees problems as a challenge
* A proactive, open personality, which is characterized by a high level of service

Reference No.: 921211SGR
Role: System product engineer / scientist R&D
Industry: Pharma
Location: Rotkreuz
Workload:100%
Start: 01.04.2022
Duration: 12++
Deadline: 07.02.2022

Should you find yourself suitable for this position then please send us your complete CV using the link in this advert. If the position is not a perfect match and you wish to receive other opportunities directly, you can send us your CV anyway via this advert or to jobs[at]itcag[dot]com.

Contact us for further information regarding our company, our positions or our attractive payroll-only-program: +41 41 760 77 01.

About us:

ITech Consult is a certified ISO 9001:2015 Swiss company with offices also located in Germany and Ireland. ITech Consult is specialised in delivering IT and Life Science candidates for contract work. We were founded in 1997 by IT professionals; hence we well understand what it means to be professionally supported in your search for a new project and being employed.