We are recruiting for a highly-driven Staff Systems Engineering position to work with a cross-functional team to develop and sustain Flow Cytometry technologies and corresponding automation systems. The Staff Systems Engineer will drive technical aspects of projects focusing on complex cell analysis systems and solutions. The candidate will function within a group that acts as the hub of product development within the R&D organization defining the direction of performance requirements, interfaces, subsystem trade-offs and traceability of design control requirements.
This role involves utilizing technical knowledge and engineering tools and methodologies to define and connect pieces across different functional elements (Software, Mechanical, Electrical, Fluidics, and Optics) within a regulated environment. You will ensure the product requirements are defined/maintained and the lower-level functional design teams deliver to those requirements.
- Define and drive system-level requirements and architectural decisions
- Communicate with users, scientists, and customer-facing associates like marketing and field service associates to finesse the customer experience
- Develop system and subsystem requirements. Play an essential role in Risk Analysis and FMEA files
- Develop and execute formal and informal test protocols. Use finding to drive decision-making and iterate on the design
- Utilize modeling tools to simulate and analysis systems, subsystems and data
- Communicate requirements and results with the cross-functional teams
- Provide technical expertise to within the Systems Engineering team and cross-functional project teams to support development and submission objectives
- Contribute to best-in-class systems engineering functional excellence, including data-driven approach with focus on superior user experience
- Participate in Design and Technical Reviews to ensure sound decision making is made across the program
Education and Experience:
- Minimum of a Bachelor’s degree in an engineering discipline, e.g. Biomedical, Electrical, or Mechanical. Graduate degree is highly preferred.
- 10+ years of hands-on experience in sample and test automation is highly desired
- 10+ years of hands-on experience in one or more areas related to flow cytometry or cell analysis such as signal processing, embedded systems, electronics, software, fluidics, optics, and/or assay reagents strongly preferred.
- Experience in experimental techniques, statistical analysis & engineering investigation techniques.
- Experience with medical devices or IVD systems required.
- Experience in a regulated environment is preferred.
- Familiar working with external contract design and manufacturing facilities.
- Familiarity with regulations and compliance testing is desired.
- Familiarity with requirement management tools is desired
Very competitive salary and benefits!
Great company to work for!
Full relocation package is available!
Don't miss out! Apply now and we'll be in touch immediately with more specific details, salary information and to answer any questions!!
This position does NOT provide sponsorship so please do NOT apply if you require sponsorship. Thank You
KP Recruiting Group
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