Rachel Foreman Email & Phone Number

United States

Irvine, California, United States

Irvine, California, United States

Irvine, California, United States

• Authored / Reviewed Technical Documentation for submission of a Class III medical device
• Authored non-clinical portions of TD
• Reviewed all sections of TD and formatted final TD for submission to notified body
• Write timely responses to requests after TD submission- Author / Review FDA (EFS, IDE, PMA), EU, and Health Canada regulatory submissions and assessments for existing clinical and commercial Class III medical devices.

Irvine, California

• Supported PASCAL program clinical design freeze through commercialization, including designing, testing, and implementing product and manufacturing updates- Sustained PASCAL R&D activities after EU commercialization.
• Supporting product transfers to Ireland and Singapore
• Ongoing supplier activities to support Global Supply Chain second sourcing efforts
• Complaints handling and root cause investigation
• Biocompatibility assessments for post-commercialization changes- Partnered with regulatory affairs to respond to regulatory body queries in a concise and timely manner to successfully meet approval timelines.

Irvine, California

- Managed a project to modularize the cleaning process and increase cleaning capacity for Advanced Technology implant and delivery system components- Collaborated with microbiology, biology, and chemistry SMEs to prove the efficacy of the new cleaning equipment/system- Authored and executed numerous IQs to qualify existing and new equipment- Wrote set-up.

Northridge, CA

- Generated a funding proposal and negotiated a 44% increase in annual budget - Liaison to ASME competition committee, sponsors, vendors, and other resources - Organize and maintain scheduling and execution of all events (e.g. PDR, CDR, etc.) - Interpret and ensure adherence to rules and procedures of competition - Supervise and guide four team members to.

- Tutor college students in mathematics, effectively raising passing rates for entire classes and individual students- Grade assignments and proctor exams for over 40 students at a given time

- Researched the effect of orientation on properties of an EVA/polyurea bilayer - Developed COMSOL FEA simulation to model bilayer behavior under compression - Created DOE and prepared samples for testing in Dynamic Mechanical Analyzer

Valencia, CA

- Executed 9 IQs and 2 OQ/PQs to complete a major cleanroom line move - Characterized and validated a weld procedure and wrote an OQ/PQ for attaching cable to platinum contacts for spinal cord leads in high volume production - Investigated, evaluated, and implemented CAPAs - Participated in creating FMEA for new spinal cord lead processes - Streamlined the.

Greater Los Angeles Area

- Successfully persuaded new schools to enroll in the enrichment program - Supervised, trained, and maintained schedules for multiple coaches - Communicated with parents, teachers, and school administrators to encourage program participation and facilitate classes

Bachelor Of Science (B.S.), Mechanical Engineering, Senior

Activities and Societies: Tau Beta Pi Engineering Honor Society, Society of Women Engineers, Women's Soccer Club

Mathematics And Computer Science

Activities and Societies: NCAA Soccer, NCAA Track & Field Spent two years at University of Redlands studying Math and Computer Science.