Product Quality Engineer – NPI (Medical Device Industry)

About Bright Uro: 

Bright Uro is a fast-growing medical device startup headquartered in Irvine, CA. Our mission is to improve the lives of millions affected by lower urinary tract symptoms (LUTS) by developing cutting-edge diagnostic technology that combines advanced hardware, intuitive software, and powerful data analytics – making it easier for clinicians to gain actionable insights while delivering a better patient experience.  Our passion lies in advancing urologic care through innovation and building a collaborative, dynamic team to bring transformative solutions to life. 

About the Role: 

We are seeking a skilled and experienced Product Quality Engineer to join our team. The ideal candidate will have a minimum of 4 years of quality engineering experience with an emphasis on NPI and Sustaining Engineering in the medical device industry. This role is critical to ensuring the performance, reliability, and sustainability of all devices manufactured by Bright Uro.   

Bright Uro is a dynamic startup with a game-changing urology device that already has interest from medical providers. Our team is small but growing; we are hiring people who want to help build this company with us with a focus on excellent work and culture. The NPI QE role in particular has the opportunity to both learn and contribute, being a key player on the team with the ability to build your own career in the company. 

Duties and Responsibilities:  

• Support the senior members of staff in design and manufacturing reviews 
• Write procedures and work instructions that define and govern the quality system 
• Evaluate nonconforming material and disposition based on cross-functional engineering reviews 
• Generate DFMEAs/UFMEAs and participate in risk analysis discussions 
• Develop inspection strategy and methods to support the development and launch of new products 
• Review and in some cases approve design and development documentation 
• Provide support for design quality in ISO and FDA audits 
• Author procedures and work instructions that define and govern the quality system 
• Participate in internal audits of the quality system and other business functions 
• Assure compliance to internal and external specifications and standards (i.e. GMP, ISO, FDA, MDD) 
• Review trends in device failures associated with customer complaints and nonconforming material 
• Lead and own corrective and preventive actions and complaint investigations 

Skills and Requirements:  

• Bachelor's degree in Engineering or Physical Sciences 
• 4 years of QE experience, with 3 years in the medical device industry 
• Technical report writing and review experience 
• Design controls, risk management, statistics, test method validation, and new product development processes 
• Knowledge of industry regulations such as ISO13485 and FDA QSR’s 
• Knowledge of ISO 14971 and risk management principles 
• Excellent verbal and written communication skills, including the ability to contribute technically to and work within cross-functional team environments 
• High personal/professional integrity, trustworthiness, strong work ethic, and ability to work independently 
• Ability to work in a dynamic and collaborative environment and maintain a results-oriented, positive, “can-do” attitude and ability to work well under pressure 
• Strong organizational and multitasking skills, with a high level of attention to detail and proactive approach to problem-solving 

Nice to Have:  

• Prior startup or early-stage company experience