Leah Rosenthal Email & Phone Number

Redwood City, California, United States

San Francisco Bay Area

San Jose, Ca

San Jose, Ca

Responsible for the supervision of Quality Control technicians performing pass/fail quality inspections on finished medical devices for entire endoscopy division and the creation of product specific paperwork and labeling. Created methods of reporting on daily metrics, 12 month capacity analysis, scheduling, and goal attainment across the team. Identified and drove quality improvement initiatives and led team based process improvement projects resulting in an efficiency gain of 1.5 heads, reduction in human error and increased ergonomics. Restructured team across business units to better serve organizational goals and use of resources while keeping team engagement and expectations high. Planned team engagement activities and developed team members in areas of necessary growth and career interests.

San Jose, Ca

Managed team of 33 specialists working in OR environments across Northern CA, Washington, Oregon, Reno and Hawaii. Worked closely with hospital administrators and sales team to ensure successful staffing, on boarding, training, and continued performance of team members at each site. Hired and on boarded over 15 specialists across the growing region, reported on team metrics, scheduling, and resource management.

Mountain View, Ca

Supported daily production of Neurovascular clot retrieval devices, worked as integral part of new product introduction teams to support launch of new product iterations.Investigated root causes of manufacturing and incoming material issues, completed corrective and preventative actions through NCR and CAPA systems, led cross functional team to coordinate solutions to ensure no impact to customer serviceSite representative for human error reduction program, attended corporate training, lead site improvement efforts and increased assessment score beyond improvement goal, received divisional exemplary quality improvement award for effortsFounded event planning committee to improve company culture and employee engagement, board member of divisional Stryker Woman’s Network committee and divisional activities committee, active member of Lean Sigma Council

Fremont, Ca

Supported production of medical grade extruded tubing used for Neurovascular stent delivery catheters. Performed statistical analysis including best normality fits, Ppk and Cpk values using Minitab.Updated procedural documents to reflect current processes by observing and working closely with assemblers.Audited the manufacturing line, identified and resolved gaps in documentation making line audit ready.

Sunnyvale, Ca

Wrote test strategies for new software features, developed and ran automated tests usingartificial heart rhythms.Completed human factors usability testing by interviewing industry professionals, compilingresults and presenting suggestions for development of new feature details.Analyzed system tests of device behavior, reported and investigated issues and bugs in thesystem.

Sunnyvale, Ca

Acted as lead firmware requirements engineer on a project with new firmware features, created firmware requirements for new device features and enhancements for pacemakerand ICD devices.Balanced requirement development and support across multiple simultaneous projects, implemented new processes to enhance consistency and quality.Served as Scrum Master for Agile teams of up to 9 people to remove road blocks andmanage resources for month long sprints.Designed cross-site tutorials and led training for large groups.Oversaw multi team collaboration to create submission documents for FDA submission.

Fremont, Ca

Supported production of Neurovascular stent delivery systems and Imaging catheters, completed line support tasks such as change requests, non –conformance reports, IQs, PQs,CAPAs and manufacturing procedural updates.Tracked reasons for scrapped materials to investigate production issues, investigated and solved manufacturing issues to improve product yield, Updated scrap documents to improve scrap identification and classificationAudited the manufacturing line and identified and resolved gaps in documentation to makeline more audit ready