Senior Manufacturing Engineer Endiatx - 3.5 Hayward, CA Job Details Full-time $135,000 - $175,000 a year 2 hours ago Qualifications Developing medical devices Industrial equipment design Manufacturing management New product introduction engineering projects Operations management Engineering development testing Procedural guides Team leadership Technical documentation Technical writing experience within manufacturing Equipment troubleshooting Assembly fixtures GD&T Project management experience in manufacturing Factory operations documentation First article inspection Manufacturing facility experience Team development Mechanical drawings Production validation processes Bachelor's degree Medical device manufacturing facility experience Technology transfer (scale-up process) Quality control Mentoring Design engineering Design for manufacturability (DFM) Managing projects Technical troubleshooting support Mechanical product validation projects Full Job Description Senior Manufacturing Engineer Endiatx, Inc. | Hayward, CA | Full-Time About Endiatx Endiatx is a medical technology company developing next-generation medical robotic systems for gastrointestinal applications. Our team is building innovative diagnostic and interventional technologies designed to expand how physicians visualize, navigate, and interact with the GI tract. We are a hands-on, multidisciplinary team working across robotics, medical devices, imaging, software, manufacturing, clinical development, and regulatory affairs. As we advance our products through regulatory submission and toward commercialization, we are continuing to build the Quality and operational infrastructure needed to support the next stage of the company. The Role The Senior Manufacturing Engineer will be a key technical and operational member of the team responsible for manufacturing processes, production readiness, design transfer, and day-to-day manufacturing execution. This is a hands-on role for an experienced engineer who is comfortable moving between product development, the manufacturing floor, suppliers, and Quality. The individual will work closely with Mechanical, Electrical, Software, Quality, and Operations to develop robust and scalable manufacturing processes for complex medical devices. In addition to manufacturing engineering responsibilities, this person will supervise the manufacturing line and provide day-to-day leadership to Manufacturing Technicians, including work prioritization, training, troubleshooting, and production support. The ideal candidate combines strong medical-device manufacturing experience with practical leadership skills and remains comfortable working directly with hardware, tooling, and production personnel. Key Responsibilities Lead development, implementation, validation, and continuous improvement of manufacturing processes for medical devices and associated assemblies. Lead manufacturing readiness and design transfer activities as products transition from R D into controlled and commercial production. Partner with product-development teams on DFM/DFA, tolerance analysis, material selection, assembly methods, and manufacturability. Develop and maintain manufacturing work instructions, process specifications, inspection methods, tooling, fixtures, and production documentation. Lead process characterization, equipment qualification, and process validation activities. Supervise day-to-day manufacturing line activities, ensuring production priorities, processes, documentation, and Quality requirements are followed. Manage and mentor Manufacturing Technicians, including task assignment, training, technical support, performance feedback, and development. Coordinate manufacturing schedules and resource needs with Operations and Engineering. Support prototype, engineering, verification/validation, pilot, and production builds. Troubleshoot complex manufacturing issues and lead root-cause investigations, corrective actions, and process improvements. Establish and monitor manufacturing metrics related to yield, quality, throughput, efficiency, and process capability. Partner with Quality on nonconformances, deviations, CAPAs, rework, inspection methods, process validation, and manufacturing risk management. Work with Quality and Engineering to establish incoming, in-process, and final inspection requirements. Support technical interactions with suppliers and contract manufacturers, including process development, manufacturing transfer, troubleshooting, and supplier improvement. Support First Article Inspection, component qualification, supplier qualification, and supplier process changes. Evaluate design and process changes for manufacturing impact and support appropriate change-control activities. Improve manufacturing efficiency, repeatability, scalability, and cost while maintaining product quality and regulatory compliance. Help develop the manufacturing infrastructure, processes, equipment, and team needed to support commercial growth. Qualifications Bachelor's degree in Mechanical Engineering, Manufacturing Engineering, Biomedical Engineering, or a related engineering discipline. 5-8+ years of relevant manufacturing engineering experience, within the medical-device industry. Demonstrated experience independently owning manufacturing processes and driving products from development into production. Experience supervising, mentoring, or providing technical leadership to manufacturing technicians or production personnel. Strong understanding of mechanical assemblies, engineering drawings, tolerances, GD&T, materials, and manufacturing processes. Experience with DFM/DFA and design transfer. Experience developing manufacturing documentation, work instructions, process specifications, and inspection requirements. Experience designing or developing manufacturing fixtures, tooling, and production equipment. Experience with process characterization, qualification, and validation. Strong troubleshooting, root-cause analysis, and structured problem-solving skills. Experience working directly with suppliers and contract manufacturers. Ability to independently prioritize and drive multiple manufacturing projects. Strong written and verbal communication skills. Comfortable operating in a fast-moving startup environment with evolving products, processes, and production needs. Preferred Qualifications Significant experience in the medical-device industry, particularly within an

ISO 13485

Quality Management System. Experience supporting Class II medical devices or similar regulated products. Experience bringing medical devices through design transfer and into commercial manufacturing. Familiarity with FDA medical-device manufacturing requirements, design controls, and Quality System requirements. Experience with IQ/OQ/PQ or equivalent process-validation methodologies. Experience with complex electromechanical, robotic, imaging, endoscopic, or miniature medical devices. Experience with supplier qualification, supplier audits, and supplier process development. Experience with statistical process control, DOE, process capability studies, and manufacturing data analysis. Experience with PFMEA, nonconformance investigations, CAPA, and manufacturing risk management. Experience scaling production from low-volume development builds into higher-volume manufacturing. Experience building or managing a small manufacturing team. Location On-site in Hayward, CA, Limited hybrid flexibility. Compensation $ 135,000 - $ 175,000 base salary, plus equity and benefits. Work Authorization Must be authorized to work in the U.S. Equal Opportunity Endiatx is an equal opportunity employer. Accommodations Reasonable accommodations provided. Employment Status At-will employment.

Pay:

$135,000.00 - $175,000.00 per year Application Question(s): Do you have a Bachelor's degree in Mechanical Engineering, Manufacturing Engineering, Biomedical Engineering, or a related engineering discipline?

Education:

Bachelor's (Required)

Experience:

manufacturing engineering within the medical-device industry: 5 years (Required) supervising, mentoring, or providing technical leadership: 2 years (Required) assemblies, drawings, tolerances, GD&T, and materials: 3 years (Required) DFM/DFA and design transfer: 2 years (Required) working directly with suppliers and contract manufacturers: 1 year (Required) owning manufacturing processes: 2 years (Required) process specifications and inspection requirements: 2 years (Required) developing fixtures, tooling, and production equipment: 2 years (Required)

Medical Device Industry:

1 year (Required) process characterization, qualification, and validation: 3 years (Required)

Work Location:

In person