Senior Manufacturing Engineer (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 an experienced Senior Manufacturing Engineer to drive the scalability, efficiency, and reliability of our medical device manufacturing processes and device improvements. This role will focus on transitioning new and evolving product lines into high-volume production while ensuring compliance with industry standards, optimizing processes, and ensuring manufacturability. The ideal candidate will be hands-on and capable of working cross-functionally with Production, R&D, Quality, Regulatory, and suppliers to implement best-in-class engineering solutions. This is a dynamic role for an engineer who thrives in a fast-paced manufacturing environment and is passionate about driving innovation, efficiency, and quality in medical device production. If you are a hands-on technical leader with a proven track record in manufacturing excellence, we encourage you to apply! Duties and Responsibilities: New Product Introduction & Process Development: Lead the transition of non-mature product lines into scalable, high-efficiency manufacturing processes. Conduct Design for Manufacturability (DFM) and Design for Assembly (DFA) reviews to optimize product designs for production. Develop and refine assembly workflows, fixtures, and equipment to improve repeatability, throughput, and yield. Establish and execute validation strategies (IQ/OQ/PQ) for new products, processes, and equipment in compliance with ISO 13485 and FDA regulations. Identify and engage with vendors to develop contracts and OEM manufacturing solutions. Process Optimization & Continuous Improvement: Utilize Lean Manufacturing methodologies to eliminate inefficiencies and enhance production yield. Implement data-driven problem-solving techniques, such as root cause analysis and risk mitigation strategies. Optimize workstation layouts, assembly line flow, and ergonomic considerations to improve operator efficiency. Research, recommend, and implement new technologies and manufacturing methods to enhance operational performance. Fixture, Tooling & Equipment Development: Specify, select, install, and validate manufacturing tools, fixtures, and automation solutions. Support semi-automated and manual assembly processes, integrating scalability and long-term reliability. Vendor & Supply Chain Management: Assess and manage vendors to ensure components and finished goods meet technical and quality standards. Develop global, cost-effective manufacturing strategies through contract and OEM relationships. Evaluate supplier capabilities and implement vendor partnerships with Purchasing and Quality teams to ensure optimal performance. Shop Floor Engagement & Technical Expertise: Work closely with Production teams to troubleshoot and resolve real-time manufacturing challenges. Mentor and provide leadership to Manufacturing Engineers, guiding them in engineering principles and best practices. Required Qualifications: Bachelor’s degree in Mechanical or Manufacturing Engineering, or similar, with 5+ years of experience in manufacturing engineering, with a focus on medical device assembly, catheter assembly, and high-volume production, or equivalent education and years of experience. Extensive experience in validation protocols (IQ/OQ/PQ), risk mitigation, and regulatory compliance (FDA, ISO 13485, GMP). Proficiency in SolidWorks and tolerance stack-up analysis. Comfortable working directly with production teams. Demonstrated experience in cross-functional team support within medical device manufacturing. Background in vendor management, outsourcing, and supplier qualifications. Excellent communicator and collaborator who enjoys working across teams. Strong attention to detail and a proactive, solutions-oriented mindset. Organized and capable of juggling multiple priorities in a fast-moving startup. Have a high degree of integrity, accountability, and a passion for doing things the right way. Nice to Have: Prior startup or early-stage company experience. Familiarity with Microsoft Teams. Physical Requirements: Ability to lift up to 25 lbs. Able to work extended periods sitting or standing based on project needs.