Christian Mast
Senior Manufacturing Engineer @ EBR Systems, Inc.
About
Mechanical Engineer with a strong background in medical device manufacturing, product development, and process validation within startup environments. With experience in design verification, root cause analysis, and Six Sigma methodologies, I thrive in developing and optimizing manufacturing processes to improve the quality for complex medical technologies. I have successfully executed process validations, developed product requirement specifications, and led investigations into critical device performance issues—resulting in enhanced product reliability and streamlined production. My expertise in statistical analysis, design of experiments (DOE), and risk management (DFMEA/PFMEA) allows me to drive data-driven solutions that improve device performance and patient safety. Passionate about medical innovation, I am always seeking opportunities to contribute to cutting-edge product development and collaborate with cross-functional teams to bring life-changing devices to market.
United States
San Francisco Bay Area
Medical Device
Supplier Management, Statistical Process Control (SPC), Material Characterization, Gage R&R, Test Method Validation, Microsoft PowerPoint, Microsoft Excel, Critical Thinking, Technical Documentation, Quality Management, Failure Analysis, Equipment Qualification, Process Capability, Design for Manufacturing, Fixture Development, Documentation, Micro-Vu, Problem Solving, Product Development, Tolerance Analysis
Experience

Manufacturing Engineer
Mavericks Endo, Inc. (The Foundry)
Delivery system and implant manufacturing

R&D Engineer
Mavericks Endo, Inc. (The Foundry)
Menlo Park, California, United States
Delivery system R&D Engineer

Manufacturing Engineer
Pleasanton, California, United States
Conducted a Design of Experiment (DOE) to characterize the sealing process for creating a sterile barrier for the medical devices. The DOE results led to a significant process improvement by widening the operating range, demonstrating that seals could be consistently manufactured with a heating temperature variation of 5% from nominal parameters. Identified a significant manufacturing issue with the packaging component for the device. Through collaborative efforts with the supplier and root cause analysis, NCMRs and RMAs were issued for lots, and corrective measures were established to ensure consistent compliance with the specified requirement and to prevent potential product launch delays. Generated a process validation protocol for the sterile barrier manufacturing process, including operational qualifications (OQ) and performance qualifications (PQ). Collaborated with operators to execute the validation, conducting a process capability analysis to ensure consistent, high-quality results and effectively reduce defective parts per million Designed and implemented a manufacturing fixture to address operator fatigue issues in an assembly process. This fixture improved the manufacturing process by alleviating the physical strain on operators' fingers, ensuring improved efficiency and reduced fatigue-related issues. Conducted a thorough characterization of the catheter’s outer jacket material by developing a series of test methods. Results provided crucial insight into the material properties, identifying a 25% increase in wall thickness after lamination across all lots, and a negative correlation between wall thickness and material elongation. Performed time studies on different manufacturing processes and supplied the collected data to a senior engineer. This data was then used to create an approximation for the total build time for a device. Developed a test method needed for in-process monitoring, referencing ASTM F88.

Research & Development Engineer Intern
Pleasanton, California, United States
Performed end-to-end product development tasks encompassing the conceptualization and realization of a test fixture, alongside conducting mechanical tests to evaluate various functions of the medical device.
Education

Mechanical Engineering, Concentration in Biomechanics
Technical Courses: - Human Centered Design Methods - Advanced Orthopedic Biomechanics - Advanced Structural Aspects of Biomaterials - Advanced Augmentation of Human Dexterity Leadership Courses: - Accounting & Finance for Engineers - Communications for Engineering Leaders - Product Management for Engineering Leaders - Organizational Behavior for Engineers - R&D Technology Management & Ethics - Teaming & Project Management

Mechanical Engineering
Milestones & Accomplishments: 3x Undergraduate Research Opportunity Program recipient for leading research guided projects, the UCI Solar Car team and BiNoM lab As Project Manager of the Solar Car team, I led the team from the research and development phase to production while increasing funding by $3,000
Christian Mast's Contact Information
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