Boston, Massachusetts, United States
Experienced Mechanical Design Engineer with a demonstrated history of working in the mechanical or industrial engineering industry. Skilled in AutoCAD, SolidWorks, Manufacturing Engineering, Arduino, and U.S. Food and Drug Administration (FDA). Strong engineering professional with a Bachelor’s Degree focused in Biomedical/Medical Engineering from Boston University.
• Collaborate closely with cross-functional design and product development teams to facilitate a smooth handoff of new product designs to the manufacturing environment, ensuring full compliance with medical device regulations. • Spearhead the implementation of efficient, scalable manufacturing processes and workflows for the introduction of novel medical devices, drawing from expertise in rapid-prototyping and volume manufacturing techniques. • Ensure that all manufacturing documentation including work instructions, process flow diagrams, and validation protocols, are thoroughly developed and maintained. • Liaise with suppliers and vendors to coordinate the timely delivery of critical components and materials, while maintaining traceability and quality control.
• Collaborated with contract design engineers to design and test mechatronic diagnostic instruments that were ultimately FDA cleared for clinical diagnostics • Led mechanical design projects to facilitate improved reliability and performance of instrumentation • Designed, prototyped, tested, and implemented field service tools to improve maintenance time and robustness of calibration and teach • Iterated on consumable designs to improve user experience based on customer and marketing feedback • Performed tolerance analysis on instrument sub systems and consumables to drive manufacturing needs • Worked with the field service team to quickly root cause and fix instrument issues at customer sites • Took contract manufacturer feedback to improve manufacturability of complex fluidics sub-assembly • Ensured that all design and testing activities were performed within the Selux Quality Management System (QMS) • Mentored Co-ops through various design projects from ideation to fabrication
• Collaborated with a project engineer to design and manage an actuator design that would go on a class IIb robotic surgical device for clinical studies and doubling production • Designed a new production line with assembly breakdown to implement lean manufacturing principles to improve efficiency • Created test fixtures to improve current test procedures so that technicians are able to easily test and qualify actuators • Worked with vendors and suppliers to obtain compliance documents, design reviews, and update our equipment to streamline our assembly process and meet our customer standards for a medical device • Conducted design changes and reviews of the actuators that would be assembled on the surgical robot • Managed day to day production of the assembly line for the actuators which included quality, packaging, shipping, and providing engineering support
• Collaborated with client’s robotic team to develop and design new structures for their new fulfillment centers in Japan to improve productivity • Created sheet metal designs to improve the structural design on fulfillment stations, and conducted tolerance analysis for the assemblies for the client’s stations • Designed and supported a robotics company’s next generation warehouse robotics by redesigning the electric enclosure for it to be more user friendly, water proof, and modular • Designed a test fixture for client’s new robotic device to be able to move 75 lbs using DC motors. • Collaborated with a design team to create a novel surgical drape which enabled enhanced digital display visibility for medical personnel • Conducted a tolerance analysis on a client’s new class III medical device in order for it to be ready for production • Designed a new fixture for a client’s novel medical device to ensure ease of manufacturability. Testing was also done on simulation fixtures to make sure that the devices were ready for V&V validation
• Corvia Medical is a small (~30 employee) medical device start up focused on developing the first transcatheter device to treat heart failure with preserved ejection fraction (HFpEF). • Worked with R&D and Manufacturing to support early stage development of Corvia’s next generation device by participating in concept development, assisting in CAD design and manufacturing of prototypes. • Used Formlabs 3D printer to create components for an ergometer (exercise bike) used for qualifying patients for Corvia’s pivotal clinical trial instead of outsourcing the job, reducing cost and lead time for each part. • Wrote and executed Installation Qualifications (IQs) of a heat sealer which included testing its safety alarms, electronic components, inputs and outputs, and testing the machines parameters. • Initiated engineering change orders (ECO’s) to modify test and manufacturing equipment profiles, purchase specifications, test procedures, manufacturing procedures, design master records, and inspection procedures. • Managed vendor for catheter packaging along with changing the design of the package to better secure the product.