The Systems Engineer will apply in-depth knowledge of systems engineering principles, theories, concepts, and techniques and ensures that components, modules, and subsystems are integrated successfully into the final hematology products. She/He drives requirements into system and subsystem definitions, supports the capture and tracking of technical risk parameters, and advises the team on the selection and deployment of appropriate tools and standards. The candidate will develop studies and experiments to characterize and verify systems and perform analysis of test results including the preparation of comprehensive reports.
- Define system requirements and prepare written specifications in DOORS; break down high level feature requirements and use case specifications into functional requirements to an appropriate level of detail suitable for use by verification testers.
- Support all engineering activities related to product and process development during project phases in accordance with design controls for large, complex IVD systems.
- Select and develop integration testing techniques for ensuring the systems’ overall capability to satisfy requirements.
- Develop test plans and test protocols; perform troubleshooting, diagnoses and resolve problems to component, module, and system level.
- Lead cross-functional teams in design reviews, risk management activities, dFMEA, pFMEA.
- Apply Design Control / Design for Six Sigma including experimental techniques, statistical analysis & engineering investigation techniques (DMAIC, DoE etc).
- Perform calculations and engineering analyses and generate graphical representations necessary to define the new concepts developed by using scriptinglanguages like Python, Matlab, Labview.
- Produce high quality documents and written reports, describing test-related topics in a clear and concise style and in full accordance with the organizational processes.
- Support installation maintenance and repair of internal instruments and support service activities during the development process.
- Ensure compliance to organizational policies, procedures, and quality requirements in an FDA-regulated environment.
Bachelor's Degree in an Engineering or closely related discipline with two to four years of related work experience or sufficient transferable experience to demonstrate functional equivalence to a degree. Minimum 2 years’ experience.
- Bachelor’s degree in the field of Systems or Biomedical Engineering with 5+ years minimum direct work experience in a laboratory setting or Master’s degree with 3+ years of experience.
- Experience in Flow Cytometry and the integration with large, complex medical, IVD, and/or analytical instruments highly desired.
- Previous Design Control / Design for Six Sigma experience including experimental techniques, statistical analysis & engineering investigation techniques (DMAIC/six sigmagreen belt an asset).
- Strong background in CAPA, DoE, DMAIC etc. to develop best practices in integrated system development.
- Deep understanding of product requirements, risk analysis, FMEA, and quality systems.
- Excellent technical writing skills and good documentation practices.
- Knowledge of scriptinglanguages like Python, Matlab, Labview required