Principal Reliability Engineer

The Principal Reliability Engineer is part of Alcon's Engineering function, a team focused on improving quality, processes, products, packaging and materials across our business to help deliver brilliant outcomes and will be located at our R&D facility in Lake Forest, CA.
** In this role, a typical day will include:
*** 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 with 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 through Design Control process, plans, verifications, and validations are compliant, documented, timely, and grounded in solid science.
** Skills*** 7 yrs hands-on design and/or DfR experience on highly varied products, Complex opto-electro-mechanical system 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 ( 7 yrs.) hands-on experience in product development and design
* Hand-On Experience and conceptual understanding of reliability tools such as ALT, HALT, Environmental Tests, DFMEA, DfR, RBD, RCA, and FTA
* 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 such as CAN bus and ethernet, and test programming
* Proven strong learning agility required
* Familiarity with applying basic statistical concepts and using statistical software packages in reliability analysis (e.g. Reliasoft, Minitab, Matlab, SPSS, R, etc.) such as Weibull, sample size and confidence
* Familiar with GMP/QSR (FDA 21 CFR Part 820) aspects applicable to medical device development
* Practical experience in Design Control process of Medical Device design and development per FDA guidance
* 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…