The 'design transfer' from R&D to manufacturing is a highly formalized process in medical devices. The Design Transfer Plan (DTP) is a comprehensive document listing all equipment, procedures, sub-assemblies, and planned validation activities (PQs, OQs, TMBs), plus formal assessments from regulatory and quality teams before production can begin.
Instead of a linear career path, Yesenia Avellaneda took a two-year break after college to explore unrelated fields like sports reporting and pageants. This period of uncertainty was crucial for her to discover her passion for biomedical engineering, demonstrating that a non-linear journey can be highly effective for self-discovery.
Scaling manufacturing isn't a fast ramp-up. For a complex catheter, increasing output from 800 to 5,000 units per month took a year and a half. This required a multi-phased approach that balanced market demands with quality, careful capacity planning for machinery and headcount, and correcting initial assumptions along the way.
To prevent teams from getting lost in day-to-day tasks, Sr. Project Engineer Yesenia Avellaneda opens every project meeting with a slide showing the key milestones. This simple, repetitive action constantly realigns the team on the ultimate goals and sets the tone for the discussion, ensuring everyone remains focused on what truly matters.
Standard project management tools like Smartsheet are often too detailed for executive updates. Yesenia Avellaneda uses a specific PowerPoint add-on, Office Timeline Pro, to create clean, high-level visual overviews. This ensures leadership can quickly grasp project status and key milestones without getting bogged down in the minutiae.
When her team faced repeated software validation failures, the solution was not more hours. Instead, they took a complete break to walk and eat. Returning refreshed, they held a listening session and used root cause analysis tools to identify the problem, proving that disengagement can unlock solutions that intense focus cannot.