System Engineer - Medical Devices Products (m/f)

About us
Sysmex Inostics is a molecular diagnostics company that provides testing for physicians, clinical trials, and research offering highly sensitive mutation testing from plasma samples.

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
Inostics GmbH was founded in September 2008 in Hamburg, Germany.  Effective Oct 1st, 2013 Sysmex Corporation acquired all shares of the company (including its US subsidiary, Inostics, Inc.). As a consequence, Inostics has changed its name to Sysmex Inostics GmbH and Sysmex Inostics, Inc., and has become a wholly owned subsidiary of Sysmex Corporation.

Job Description

We are seeking a highly technical, experienced engineer to play a significant role in developing of instrumentation for our next generation assays

Responsibilities include:
  • 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
Other required skills and abilities
  • 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!

How to apply:
Please apply online, quoting the reference number 15-19, with your complete application documents as well as your earliest starting date and salary expectations.
Send application to
Sysmex Inostics GmbH
Human Resources
Janine Kling
Falkenried 88
20251 Hamburg
Tel.: 040/3259070
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

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