Alcon · 2 months ago
Principal Reliability Engineer
Lake Forest, California
Full-time
Onsite
Lead/Staff
$104K/yr - $156K/yr
8+ years expAlcon is a company dedicated to enhancing sight and improving eye health. The Principal Reliability Engineer will be responsible for implementing and enhancing quality and reliability systems to support R&D objectives, while ensuring product designs meet rigorous reliability and quality standards.
Health CareManufacturingMedical Device
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 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
Qualification
Required
>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)
Bachelor's degree in Electrical, Mechanical, Reliability engineering with >8 years of demonstrated success in opto-electro-mechanical systems with a reliability focus
The ability to fluently read, write, understand, and communicate in English
5 Years of Relevant Experience
Preferred
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
Benefits
Health
Life
Retirement
Flexible time off
Relocation assistance
Company
Alcon
Alcon specializes in developing and manufacturing innovative medicines and devices to serve the cycle of eye care.
10001+ employees
H1B Sponsorship
Alcon has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (27)
2024 (35)
2023 (12)
2022 (15)
2021 (45)
2020 (20)
Funding
Current Stage
Public CompanyTotal Funding
unknown2010-12-15Acquired
2002-03-21IPO
Leadership Team
David Endicott
Chief Executive Officer
Tim Stonesifer
Chief Financial Officer
Recent News
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