Principal Reliability Engineer

Alcon • Lake Forest, CA

64d • $104,000 - $156,000

About The Position

At Alcon, we're passionate about enhancing sight and helping people see brilliantly. With more than 25,000 associates, we innovate fearlessly, champion progress, and act swiftly to impact global eye health. We foster an inclusive culture, recognizing your contributions and offering opportunities to grow your career like never before. Together, we make a difference in the lives of our patients and customers. Are you ready to join us? 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.

Requirements

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

Nice To Haves

• Advanced EE, ME, and RE engineering degree highly preferred.
• >3 years in medical device product development role.
• >3 years progressive work experience in reliability engineering of NPD.
• Experience with troubleshooting and root cause analysis of opto-electro-mechanical systems.
• Experience with Laser, OCT, small Motors, Pumps, Valves, Optics, and Sensors.
• CRE certificate.

Responsibilities

• 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 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.

Benefits

• Health insurance
• Life insurance
• Retirement plans
• Flexible time off
• Relocation assistance

What This Job Offers

• Job Type: Full-time
• Career Level: Senior
• Education Level: Bachelor's degree