Senior Product Quality Engineer – NPI (Medical Device Industry - Only)

Bright Uro; Irvine (CA); On-site; USD 100,000 - 160,000; Full time

Job summary

A leading medical device startup in Irvine, CA is seeking a Senior Product Quality Engineer to ensure the performance and sustainability of their devices. The ideal candidate will bring over seven years of experience, focusing on new product introduction and compliance with industry regulations.

Benefits

Annual bonus

Stock options

Qualifications

• Minimum 7 years of quality engineering experience in the medical device industry.
• Knowledge of ISO 13485 and FDA regulations required.
• Experience with risk management and new product development processes.

Responsibilities

• Develop inspection strategy and methods for new products.
• Conduct internal audits and ensure compliance with quality standards.
• Lead corrective and preventive actions for quality issues.

Skills

Verbal communication

Written communication

Problem-solving

Attention to detail

Multitasking

Education

Bachelor's degree in Engineering or Physical Sciences

Tools

Microsoft Office Suite

Job description

Senior Product Quality Engineer – NPI (Medical Device Industry - Only)

Senior Product Quality Engineer – NPI (Medical Device Industry - Only)

Get AI-powered advice on this job and more exclusive features.

This range is provided by Bright Uro. Your actual pay will be based on your skills and experience — talk with your recruiter to learn more.

Base pay range

$100,000.00/yr - $160,000.00/yr

Additional compensation types

Annual Bonus and Stock options

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 Senior Product Quality Engineer – NPI to join our team. The ideal candidate will have a minimum of 7 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.

Essential Duties and Responsibilities:

• Participate in design and manufacturing 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 approve design and development documentation.
• Serve as subject matter expert for design quality in ISO and FDA audits.
• Author procedures and work instructions that define and govern the quality system.
• Conduct internal audits of the quality system and other business functions.
• Evaluate nonconforming material and disposition based on cross-functional engineering review.
• 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.
• Work on complex special projects as assigned.

Education and/or Work Experience Requirements:

• Bachelor's degree in Engineering or Physical Sciences is required.
• 5+ years of experience in the medical device industry.
• Proficient in technical report writing and review.
• Experience with design controls, risk management, statistics, test method validation, and new product development processes.
• Experience with industry regulations such as ISO13485 and FDA QSR’s.
• Advanced knowledge of ISO 14971 and risk management principles.

Additional Requirements:

• 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.
• Proficiency in Microsoft Office Suite (Outlook, Word, Excel, PowerPoint).

Bonus Points:

• Prior startup or early-stage company experience.
• Familiarity with Microsoft Teams.

Physical Requirements:

• Must be able to lift up to 20 lbs.
• Must be able to work extended amounts of time standing or sitting based on projects andpriorities.

Seniority level

• Seniority level

  Mid-Senior level

Employment type

• Employment type

  Full-time

• Industries

  Medical Equipment Manufacturing

Referrals increase your chances of interviewing at Bright Uro by 2x

Get notified about new Product Quality Engineer jobs in Irvine, CA.

Aircraft Engineer, Mechanical - Graduate

Huntington Beach, CA $80,000.00-$140,000.00 3 months ago

Irvine, CA $120,000.00-$160,000.00 2 weeks ago

Long Beach, CA $80,000.00-$200,000.00 2 weeks ago

Long Beach, CA $108,000.00-$138,000.00 5 days ago

Santa Fe Springs, CA $66,650.00-$90,000.00 3 weeks ago

Irvine, CA $95,825.00-$117,120.00 2 weeks ago

Manufacturing Engineer - New Product Introduction (NPI)

Exteriors, Staff Mechanical Design & Release Engineer

Irvine, CA $137,800.00-$172,200.00 1 week ago

Irvine, CA $75,000.00-$95,000.00 1 week ago

Irvine, CA $125,000.00-$169,800.00 1 week ago

We’re unlocking community knowledge in a new way. Experts add insights directly into each article, started with the help of AI.