Tracy Maahs Email & Phone Number

Irvine, California, United States

Irvine, California, United States

Irvine, California, United States

San Clemente, California, United States

● Implemented a new blower monitoring methodology, reducing start-up failures by 90%● Coordinated with our Chinese manufacturing partner to complete our first consumer order including supply chain and delivery logistics● Facilitated system cost reduction improvements of 10% in the first 6 months after launch● Wrote final inspection documentation and organized internal team to complete final inspection of products from China, insuring proper system performance

San Clemente, Ca

● Drove the development of an endoluminal access device and tissue anchor delivery catheter from concept through market release with a cross-functional team● Slashed procedure system costs by $4.6K and increased production by 400% while maintaining product quality● Managed an IP portfolio of over 90 issued patents and 7 pending applications● Coordinated and participated in over 30 pre-clinical studies with physician experts● Provided field training support for a 300-subject randomized sham-controlled clinical study● Spearheaded the selection of a CRO and guided the team through IDE approval for two pilot clinical studies

San Clemente, Ca

San Clemente, Ca

• Managed internal and external teams that designed the thermography catheter and instrument. • Wrote pre-clinical study protocols, built prototype devices and managed pre-clinicals with physicians.• Double the value of the company to $48MM with successful prototypes and pre-clinical studies in the first six months• Trained physicians in the use of the thermography system and provided technical support during initial clinical studies in Europe.

Sunnyvale, California, United States

• Co-led a cross-functional project team in the development of an interventional cardiology product, resulting in the acquisition of the product• Managed a cross-functional team in the development of a heparin-coated filter used during cardiac surgery. The technology was sold to a strategic partner.• Built prototypes and assisted in the pre-clinical testing of product in multiple studies. • Trained physicians to use the filter and balloon occluder at multiple clinical sites.

Sunnyvale, Ca

• Spearheaded a continuous improvement project that resulted in a 75% reduction in field failures. • Supervised clean room personnel during ramp-up and trained operators in product assembly,• Initiated six-sigma and lean manufacturing practices in manufacturing• Completed the justification and the implementation of in-house centerless grinding to reduce component by 50% and reduce the cycle time from 4 weeks to a few days.• Evaluated field returns, wrote reports, and implemented corrective actions.

Temecula, California, United States

• Orchestrated set up cleanroom manufacturing lines, identified capital equipment and purchased t the required equipment.• Supported a team that developed the first ultrasound ablation catheter in the field with design, CAD modeling. and prototyping.• Collaborated with physicians during animal studies to get feedback on design improvements.

Temecula, California, United States

• Learned manufacturing processes and built products in every manufacturing group which included guidewires, accessories, and angioplasty catheters.• Implement the concepts of lean manufacturing including JIT, kanban, and poka-yoke for component and fixture design.• Supervised the accessories production manufacturing lines and maintained the company goal of achieving and maintaining an 80% learning curve.• Transferred the Stack 40s angioplasty catheter from the Santa Clara R&D facility to the Temecula manufacturing site.