Reliability Engineer – Medical Devices

Job overview

The Reliability Engineer – Medical Devices role is onsite at OrthAlign’s headquarters in Irvine, CA. Compensation is not specified. OrthAlign is a growing medical device company developing smart technology. The engineer helps ensure medical devices remain safe and reliable throughout their product lifecycle. The role develops reliability requirements and verification strategies, investigates failures and risks, and supports testing and continuous product improvement in collaboration with engineering, quality, manufacturing, regulatory, and laboratory teams.

What you'll do

• Develop reliability requirements and verification strategies
• support Design for Reliability activities
• plan and execute reliability studies and validate test methods
• collaborate across R&D, Design Quality, Manufacturing, and Regulatory Affairs to mitigate risks
• analyze life data and investigate product failures
• coordinate internal and external laboratory testing
• support ISO 14971 risk management, complaint investigations, CAPA, post-market surveillance, and controlled documentation.

What we're looking for

Skills & competencies

reliability engineer

medical devices

irvine ca

orthalign

product reliability

design for reliability

failure analysis

iso 14971

electromechanical products

Work arrangement

• Weekend coverage required

Benefits & perks

• Bonus and equity, career advancement opportunities, and a full benefits package.

Why this role

Requires a bachelor’s degree in engineering, electronics, or a related field and five or more years of electromechanical product experience. The employer states it cannot provide sponsorship; candidates must report daily to the Irvine headquarters.

About the employer

OrthAlign Inc. is hiring for this role. Industry: Surgical and Medical Instrument Manufacturing. Sector: 33.