Sr. Systems Verification Engineer

4 weeks ago

San Jose, United States MILLENNIUMSOFT Full time

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

Location: San Jose, CA

Duration: 12+ Months Contract

Total Hours/week: 40.00

1st Shift

Client: Medical Device Company

Job Category: Engineering

Level Of Experience: Seniority Level

Employment Type: Contract on W2 (Need US Citizens Or GC Holders Only)

No H1B’s

Both remote and onsite, but some onsite time is required

Description:
3 Must haves on the resume:
o Minimum of a Bachelor’s degree in engineering or related discipline, e.g. Biomedical, Electrical, or Mechanical.
o Minimum of 4 years of experience in systems engineering, product development, or product design.
o 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. (equivalent experience is okay)

Strong possibility to extend an extra year or be converted for the right person.

Play a critical role in the development of life science technology in cellular analysis and corresponding automation system as a systems engineer. Participate cross-functionally in efforts to generate and maintain systems definition and documentation. Support the development of system architectures and interface designs. Utilize scientific and statistical methods to resolve problems, devise tests, and set specifications. Integrate components and subsystems to characterize system level functionality and performance. Work with the engineering staff to develop and execute experimental protocols followed by the analysis and reporting of results. Support system level engineering verification and user level validation efforts.

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 finding 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.

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