Spinout from Neptune Medical

A Shifamed company

- Mechanical engineering consultant for small PCR startup- Notable projects include LCD panel selection, flex cable relocation design, machine hinge evaluation

- Technical lead on next generation neurovascular aneurysm implant and member of R&D team supporting an IVC filter removal catheter- Characterized implant device performance by implementing new test methods, leading to new material selection and manufacturing methods- Directed prototype, pre-DV, and DV builds by generating build records, writing work instructions, and coordinating build schedules with manufacturing- Supported implant biocompatibility testing activities by researching detailed material information and providing surface area calculations

- Integral part of a small, hands-on engineering team, contributing to the entire life cycle of flagship wound protector product from prototype through commercialization - Improved early feasibility device to increase performance and meet COGs goals - Wrote detailed engineering reports to support design changes, FDA filings, and IP filings- Lead cross functional team meetings to communicate progress and schedules- Designed custom equipment to fuse thin plastic components, including mechanical design, wiring, and controller selection - Evaluated process improvement options and created a pneumatic assembly machine, merging 16 steps into one- Supported a successful US clinical trial by providing clinical field support and testing documentation for DeNovo and 510K FDA submissions (both now approved by FDA)- Planned and executed entire facility relocation on time and below budget

- Core member of the early design team responsible for the Pantheris imaging atherectomy catheter- Designed, assembled, and iterated on various concepts for cutting and removing tissue from arteries, integrating laser-based imaging systems, fluid handling systems, and rotating mechanical systems simultaneously - Technical lead for an imaging device feasibility project, creating a universal arterial imaging device- Created manufacturing instructions, tolerance stack analysis (FAI, PPL), test method protocols and reports (V&V, DV, DVAL) in compliance with an FDA quality system- Supported successful OUS clinical trials in Poland, Paraguay, Germany and Colombia - Interfaced regularly with physicians to evaluate device usage and future product improvements- Managed R&D interns by providing training and assigning weekly/long term deliverables

Merged with Avinger, Inc.

Acquired by EV3