Senior Reliability Test Engineer (Medical Devices / NPI)

Job Description:

A Senior Reliability Test Engineer at on-site, in Lake Forest, California, to work on reliability enhancement of product design for Valeda including improvements of product reliability using various engineering tools, compliance to environmental/transportation requirements, effective utilization of simulation/analysis methods, and DfX engineering design principles.

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.
• Lab Processes, Maintenance and Equipment Calibration
• Ensure compliance 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.

Qualifications:

• ≥5 years with a 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 the 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.