System Integration Engineer - Medical Devices Products (m/f)
Our core competency in mutation discovery and detection uses technologies such as BEAMing Digital PCR and Plasma- Sequencing (Plasma-Seq). BEAMing and Plasma-Seq are the most sensitive technologies available today for detecting and discovering tumor-specific somatic mutations. With our blood-based testing we deliver a non-invasive alternative for sensitive real-time molecular diagnostics to improve cancer detection, characterization and treatment.
Our services include:
- CLIA-certified laboratory in the US
- Mutation testing based on BEAMing Digital PCR and Plasma-Seq for analyzing plasma/serum and tissue (frozen/FFPE)
- Mutation assay development and validation
- Kit development
- Clinical trials testing (GCP)
- Companion diagnostics development
We are seeking a highly technical, experienced engineer to play a significant role in developing of instrumentation for our next generation assays
- Work together within cross functional team including engineering and assay development scientists on integration of new assays onto new flowcytomer platform.
- Provide input into the design of new products including instrument requirements and specifications.
- Participate in Design Reviews and provide technical input to ensure design robustness and manufacturability.
- Provide technical support throughout instrument development, hardware, software and system integration, verification and validation studies and transfer to manufacturing
- Provide technical support to investigate and assist in solving technical problems to improve their performance and manufacturability
- Failure investigation to improve product reliability based on in-house and field performance data.
- Establish standard processes for monitoring instrument performance and implementing product improvements,
Qualified Candidates will have the following background:
- BS Degree in Mechanical Engineering, Electrical Engineering or relevant engineering discipline. Advanced degree a plus
- Minimum of 5 years’ experience in medical device development in Diagnostic or Biotechnology industry
- Strong expertise in system integration of hardware, software and fluidics including performance troubleshooting and optimization
- Prior experience in reliability improvements
- Broad understanding of product development under design control and FDA regulation
- Strong experience in instrument and system verification and validation studies and transfer to manufacturing
- Direct experience with instrument service, calibration and maintenance procedures
- Strong technical, analytical and problem solving skills, as well as strong mechanical aptitude
- Excellent written and verbal communication skills, with emphasis on technical writing protocols and reports
- Working experience with FlowCytometer instrumentation is a plus
- Fluent spoken and written in English
- Able to work independently with strong work ethic
- Thrives in a fast paced, changing Environment
Interested? We are happy to receive your application with availability and salary expectation in English - quoting the Reference Number 15-19.
We look forward to hearing from you!
Please apply online, quoting the reference number 15-19, with your complete application documents as well as your earliest starting date and salary expectations.
While applying for the job please refer to jobvector and use the following reference number: 15-19
About Sysmex Inostics GmbH
Als Teil der Sysmex-Group sind wir ein international agierendes Unternehmen im Bereich der Molekulardiagnostik. Unsere Kernkompetenz liegt in der Analyse genetischer Veränderungen wie zum Beispiel Mutationen in Blut- oder Gewebeproben von Krebspatienten. Wir unterstützen internationale Pharmaunternehmen bei der Entwicklung von IVD Companion Diagnostics sowie der Analyse von...More about Sysmex Inostics GmbH