Failure Investigation Engineer

Summary

Join Calyxo, a medical device company, as a Failure Investigation Engineer. You will investigate returned products, establish investigation processes, perform root cause analysis, and work with cross-functional teams to improve product quality. This role involves using lab equipment, analyzing data, and collaborating with the Product Monitoring team. The ideal candidate possesses a Bachelor's degree in a related field, 5+ years of medical device experience, and strong analytical and communication skills. The position offers a competitive salary, stock options, employee benefits including 401(k), healthcare, and paid time off, and a remote work location.

Requirements

• Bachelor's degree in Biomedical Engineering, Life Sciences, or related field; advanced degree preferred
• 5+ years of experience in medical device industry, with focus on product failure investigations or related areas
• Experience with electrical, mechanical, and software medical device products
• Strong knowledge of medical device regulations and quality management systems
• Excellent analytical and problem-solving skills
• Proficiency in data analysis tools and statistical methods
• Strong communication and presentation skills
• Ability to work effectively in a cross-functional team environment
• Excellent level of organizational skills and ability to work on several projects simultaneously with a high attention to detail
• Open and direct communication style and a vision for continuous improvement and excellence
• Compliance with relevant county, state, and Federal rules regarding vaccinations
• Must be able to lift 10 pounds and occasionally lift and carry up to 25 pounts, sit for up to 8 hours/day, including daily keyboard data entry

Responsibilities

• Perform failure investigations on returned product using lab equipment such as flow testers, boroscopes, cameras, and hand tooling in combination with review of design documentation, system log data, and software tools
• Assist in establishing routing complaint investigation processes and procedures for returned devices
• Perform disinfection, processing, root cause analysis, disposition and tracking of returned devices
• Ensure complaint investigation files are completed in a timely manner, accurately reflecting corresponding complaint investigation activities
• Assist in providing failure investigation data to R&D and other cross-functional teams in order to to reduce occurrence rates and enhance ongoing field training
• Work with the Product Monitoring team to resolve questions around potentially reportable failures
• Work with Product Monitoring team on assessing failure trends and statistics
• Work to develop new failure codes and bucketing of failure modes as needed
• Implement corrective and preventive actions (CAPAs) as needed
• Assist in Quality System audits with various government agencies, private companies, and consultants (such as CA FDB, US FDA, etc.), and respond to any action promptly
• Perform other duties as assigned

Preferred Qualifications

Experience with Class II or III sterile devices preferred

Benefits

• Competitive salary of $125,000 - $133,000
• Stock options – ownership and a stake in growing a mission-driven company
• Employee benefits package that includes 401(k), healthcare insurance and paid time off
• Work location: Remote
• Travel: up to 5% travel