Reliability Engineer
OrthAlign Inc.•Irvine, CA
•Onsite
About The Position
OrthAlign, Inc., a Smart Technology, growing medical device company, has an immediate opening for a Reliability Engineer. The Reliability Engineer is responsible for ensuring the safety, reliability, and long-term performance of medical devices throughout the product lifecycle. The position operates cross-functionally and with external test laboratories to develop reliability requirements, identify and mitigate risks, plan and execute reliability studies, investigate product failures, and support continuous product improvement activities.
Requirements
- A bachelor's degree in engineering, electronics, or a related field of study
- Five years or more of experience in electromechanical products
- Experience with technical writing
- Strong proficiency with MS Office Suite
- Experience demonstrating a methodical approach to problem solving and data interpretation
- Ability to clearly convey technical information to cross-functional teams and stakeholders
- Ability to maintain high standards in documentation, testing, and analysis to ensure product safety and compliance
- Flexibility and strong organizational skills with ability to prioritize multiple tasks
Responsibilities
- Develop product reliability requirements and reliability verification strategies for new and sustaining medical device products.
- Support Design for Reliability (DfR) activities throughout product development and design transfer.
- Plan and execute reliability studies including accelerated life testing, accelerated aging, environmental testing, fatigue testing, and electromechanical reliability evaluations.
- Develop and validate reliability test methods and test protocols.
- Collaborate closely with R & D, Design Quality, Manufacturing, and Regulatory Affairs to identify and mitigate reliability risks throughout the product lifecycle.
- Support reliability growth activities through data-driven design improvements and verification testing.
- Develop reliability test protocols and report supporting design verification and validation activities.
- Perform statistical life-data analysis using Weibull analysis, reliability growth methods, and confidence interval calculations.
- Investigate product failures occurring during development, manufacturing, and field use.
- Conduct root cause investigations utilizing structured problem-solving techniques including 5 Whys, Fishbone Analysis, and Fault Tree Analysis.
- Coordinate reliability testing activities with internal and external laboratories.
- Support development of fixtures, test equipment, and test methodologies required to characterize long-term product reliabililty.
- Support ISO 14971 risk management activities including hazard analysis, DFMEA, PPFMEA, and risk-control verification.
- Support complaint investigations, CAPA activities, and post-market surveillance initiatives.
- Maintain reliability documentation and support controlled document revision activities in accordance with the quality system.
Benefits
- Competitive compensation including bonus and equity
- Opportunities for career advancement
- Full benefits package
- An evolving, engaging culture and workplace
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What This Job Offers
Job Type
Full-time
Career Level
Mid Level
