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Scientific. Clinical. Software Engineering

Reliability Test Engineer

Orange County Metro Area, CA

Job Type: Engineering Job Number: JN -092020-27456 Region: Orange County Metro Area

Job Description

Reliability Test Engineer

Biotech Industry

Lake Forest, CA


Hands on reliability engineer with significant laboratory experience and test set up skills.


Implements/enhances state-of-the-art quality and reliability systems/programs to support R&D objectives relating to instruments and consumables (excluding software)

Reviews/critiques product designs, proposed processes, and testing regimens with the objective of ensuring a rigorous focus on reliability, quality, and compliance throughout development process

Contributes unique expertise in key aspects of product design, including improvements of product reliability using various engineering tools, compliance to environmental/transportation requirements, effective utilization of simulation/analysis methods, and preproduction engineering design principles

Proven record of guiding/managing projects, teams, or departments to achieve timely goals while multi-tasking and meeting budget/resource constraints.

Provides expert guidance on requirements development, test planning, test execution including fixturing and automation, issue management based on upon years of hands-on experience with a wide variety of products.

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.

Provides essential analytical skills in measurement methods, stress testing, derating, reliability assessment, simulation, and evaluating alternate components.

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

Ensures teams identify and execute key pre-verification characterization testing and review activities necessary for product improvement and robustness enhancement

Works with project teams to ensure reliability, environmental, and transportation DHF deliverables, plans, verifications, and validations are compliant, documented, timely, and grounded in solid science.


Skills:


Ability to program and use common measurement equipment.

Experience writing scripts, develop fixtures, Labview, executing environmental and reliability tests preferred.

>8 yrs hands-on design and/or DfR experience on highly varied products, optics experience particularly valuable

Ability to effectively communicate complex concepts in formal/informal presentations to teams or senior management

Ability to prepare accurate highly detailed and readable technical reports.

Ability to provide expert guidance based upon:

Substantial (> 8 yrs.) hands-on experience in product development and design.

Hand-On Experience and conceptual understanding of reliability tools

Ability to design supporting fixturing, reliability test methods, identify essential testing parameters/equipment, develop test plan and implement

Practical knowledge in common failure mechanisms found on Opto-Electro-Mechanical systems

Familiar with embedded systems, communication protocols for CAN bus and ethernet, and test programming

Proven strong learning agility required

Familiarity in applying basic statistical concepts and using statistical software packages (e.g. Minitab, Matlab, SPSS, R, etc.)

Familiar with GMP/QSR aspects applicable to medical device development

Ability to critique designs for reliability, serviceability, availability, and manufacturability concerns.

Project leadership experience in transferring products from R&D into manufacturing, and leading/collaborating with multidisciplinary teams that include all functions in the manufacturing or technical services environment.

Proven ability to influence effectively in a cross-functional environment (e.g. multi-site, technical development, other functions).


Education:


BSEE/BSME or higher. Medical device experience important, must be able to prepare detailed technical reports.

BSEE or BSME Degree or 8 years of equivalent history of demonstrated success in applied electro-mechanical engineering with a reliability focus.


Preferred:


Advanced EE or ME engineering degree highly preferred

>3 years in medical device product development role

>3 years progressive work experience in reliability engineering of NPD

>2 years experience in Electrical and software for embedded systems

Experience with troubleshooting and root cause analysis of electro-mechanical systems

Experience with small Motors, Pumps, Optics, IR Laser or Sensors

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