Job Description

About Bright Uro:

Bright Uro is a fast-growing, emerging medical device company 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:

The Cleanroom Supervisor will lead and support our manufacturing team within a state-of-the-art cleanroom environment. In this pivotal role, you'll be responsible for overseeing day-to-day operations, driving production efficiency, and ensuring the highest standards of cleanliness, as well as strict adherence to quality and regulatory standards. You will play a key role in building a culture of excellence, teamwork, and accountability, while helping to deliver innovative, life-changing medical devices to patients worldwide.

Essential Duties and Responsibilities:

• Manage and supervise cleanroom operations, providing guidance, support, and ensuring production goals, quality standards, and targets are met.
• Develop deep expertise in all manufacturing processes and procedures, actively participating in production builds.
• Proactively identify and resolve manufacturing problems or challenges – and work collaboratively with the team to develop solutions.
• Foster a culture of continuous improvement by soliciting team suggestions for process optimization and efficiency.
• Ensure strict adherence to Bright Uro's Quality and Manufacturing Documentation standards across all cleanroom operations.
• Conduct regular audits and inspections to verify compliance with regulatory requirements and internal quality standards.
• Oversee and maintain accurate, complete manufacturing documentation, including build records, quality checks, and related reports.
• Identify training needs and ensure manufacturing technicians receive comprehensive instruction on processes and procedures.
• Promote an environment of attention to detail, accountability, and urgency,
• Assist in planning resource requirements and staffing to meet production demand forecasts and operational needs.

Education and/or Work Experience Requirements:

• Minimum of 10 years in medical device manufacturing, including at least 2 years in a supervisory role.
• Proven experience in cleanroom operations, personnel management, and quality control in a GMP and ISO 13485 manufacturing environment.
• Proficiency in manufacturing documentation and record-keeping, with the ability to enhance and refine procedures.
• Demonstrated technical leadership with a strong results orientation and sense of urgency.
• Ability to excel in a fast-paced, collaborative environment while fostering a positive, “can-do” team culture.
• Strong organizational, multitasking, and documentation skills, with high attention to detail and a proactive approach to problem-solving.

Additional Requirements:

• High level of personal and professional integrity, trustworthiness, and strong work ethic; able to work independently and take initiative.
• Excellent verbal and written communication skills, with the ability to effectively engage cross-functional teams.

Nice to Have:

Previous experience working in a startup or early-stage company environment.

Physical Requirements:

• Ability to lift and move objects up to 30 lbs.
• Must be able to work in a cleanroom environment all day.
• Capable of standing or sitting for extended periods based on work assignments.
• Ability to use a microscope for extended periods of time

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