Reliability Engineer

OrthAlign, Inc.; Irvine (CA); On-site; USD 120,000 - 170,000; Full time

Benefits offered by this job

Bonus & equity

Career advancement

Benefits package

Culture and workplace

Top Place to Work in Orange County

Job summary

OrthAlign, Inc. is seeking a Reliability Engineer in Irvine, CA to ensure safety, reliability, and long-term performance of medical devices throughout the product lifecycle.

You will lead reliability studies, support DfR, and collaborate with R&D, Manufacturing, and Regulatory Affairs to identify and mitigate risks. A daily report to our Irvine headquarters is required.

Qualifications

• Bachelor's degree in engineering, electronics, or related field.
• Five+ years of experience in electromechanical products.
• Experience with technical writing.
• Strong proficiency with MS Office Suite.
• Ability to communicate technical information clearly to cross-functional teams.
• Ability to maintain high standards in documentation, testing and analysis.

Responsibilities

• Develop reliability requirements and verification strategies for medical devices.
• Support Design for Reliability activities throughout development and transfer.
• Plan and execute reliability studies including life testing and environmental tests.
• Develop and validate reliability test methods and protocols.
• Collaborate with R&D, Quality, Manufacturing, and Regulatory Affairs to mitigate risks.
• Support reliability growth through data-driven design improvements and verification testing.
• Perform Weibull analysis, reliability growth methods, and confidence interval calculations.
• Investigate product failures during development, manufacturing, and field use.
• Coordinate testing with internal and external laboratories.
• Support ISO 14971 risk management activities including DFMEA/PPFMEA and risk controls.

Skills

Problem solving

Data interpretation

Cross-functional communication

Documentation quality

Multitasking/prioritization

Education

Bachelor's degree in engineering or related field

Tools

MS Office Suite

Job description

Job Description

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.

You MUST have the ability to report daily to our headquarters in Irvine, California. Candidates outside this area will not be considered.

You Will:

• 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.

You Need:

• 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

We offer:

• Competitive compensation including bonus and equity
  
• Opportunities for career advancement
• Full benefits package
  
• An evolving, engaging culture and workplace
• Nominated by our employees 2 years running as a Top Place to Work in Orange County!

It is an exciting time atOrthAlign- make your next career move with us!

NOTE: We are unable to provide any type of sponsorship at this time.