Sr. Systems Verification Engineer (Flow Cytometry Or Cell Analysis)

Job Responsibilities

• Support Systems Engineering activities and deliverables, including driving architecture and requirements for complex systems.
• Support the assessment and documentation of risk and hazard analysis
• Develop and execute formal and informal test protocols. Use findings to drive decision-making and iterate on the design
• Participate in Design and Technical Reviews to ensure sound decision making is made across the program
• Provide technical support to a wide range of problems pertaining to specific programs and projects.
• Work effectively and collaboratively in a cross-functional team and with external partners to identify, communicate, and mitigate program needs at each product lifecycle.

Minimum Qualifications

• Education and Experience:
• Minimum of a Bachelor’s degree in engineering or related discipline, e.g. Biomedical, Electrical, or Mechanical.
• Minimum of 4 years of experience in systems engineering, product development, or product design.
• 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 lab automation, Laboratory Information Systems (LIS) and 21 CFR Part 11 Compliance is highly desired
• Experience in design control in a regulated environment.
• Familiarity with external contract design and manufacturing facilities.
• Familiarity with regulations and compliance testing is desired.

Knowledge and Skills

• Knowledge in experimental techniques, statistical analysis, and engineering investigation techniques.
• Ability to plan, develop, and execute system level characterization, integration, or test procedures.
• Knowledge of system development lifecycles and requirements development process for complex systems.
• Familiar with customer, system, and subsystem level requirements management and traceability (proficiency in the use of requirements management tools such as Azure and/or DOORS).
• Good understanding of Structured Product Development Process and methodology.
• Strong problem-solving and troubleshooting skills.
• Strong technical leadership and communication skills.
• Excellent oral, written, and presentation skills.
• Experience in LabView and C programming is a plus.