Job Description

Job Description:

Q ualifications- professional services provider to:

• ≥5 years with BS Degree or 3 years with a MS Degree in ME, EE, or Biomedical Engr.
• Must include at least 3 years in R&D with primary focus on new product reliability engineering activities.
• Proven knowledge in mechanical, electrical, or optical design principles.
• Proven experience in the application of reliability engineering, including:

Some familiarity required in applying basic statistical methods.

Must be familiar with GMP/QSR regulations in Medical Device industry.

Some knowledge with embedded systems, communication protocols for CAN bus and ethernet.

Practical experience in test automation and programming SW such as LabView, Python and R.

Some experience required in fixturing, lab testing methods, Robotics and/or equipment validation.

Proven strong learning agility required.

2.2 Responsibilities

The selected provider shall deliver end‑to‑end characterization and V&V compliance support on site at the Companies office at Lake Forest, CA

1.1 Plan and Execute Test Strategy Per Reliability Plan

• Collaborates with NPI teams in identifying and executing key pre-verification characterization testing and other activities necessary for continuous product improvement and robustness enhancement.
• Plans/develops/executes automated test scripts, Labview programs, robotic programs, HALT, ALT, environmental, transportation, life testing, PCBA stress screening, engineering tests and/or V&V to ensure timely and efficacious completion of R&D development projects within budgetary and resource constraints.
• Ensures timely completion of testing with continuous feedback to development team for ongoing design enhancements.

1.2 Align Test Strategy and Logistics with Outside Labs and company QMS

• Works effectively and efficiently with internal or external labs, and product design engineers to accomplish timely and valuable results at optimal cost.

1.3 Methods & Facilities

• Reviews/critiques product designs, proposed processes, and testing regimens ensuring a rigorous focus on reliability, quality, and compliance throughout NPI.
• Uses analytical skills in statistical analysis, tolerancing/simulation, measurement science, stress testing, reliability assessment, simulation, and design critique as appropriate to support NPI Design for Reliability objectives.

1.4 Documentation and Design Control

• Works with design control functions to ensure timely corrective actions of design, assembly, supplier, or other production issues encountered during NPI.
• Works with project teams to produce RCR reports, verifications and validations are compliant, documented, and grounded in solid science.

1. Lab Processes, Maintenance and Equipment Calibration

• Ensure compliance to with QMS processes relevant to the reliability labs.
• Support all processes for handling and maintaining lab equipment including calibration and GMP practices.
• Ensure compliance to all site-specific HSE processes and requirements including laser lab safety.

2.3 Deliverables

The provider shall deliver the following, in part or in whole, depending on R&D projects’ needs, in accordance to project and reliability team leadership:

• Complete baseline characterization of six Valeda units
• Execute and complete full characterization tests of six Valeda units including some OEM modules such as LCD, cart, SBC and LEB
• Reliability characterization test procedures and reports
• Review reliability critical components and generate reliability analysis reports.

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