Justin Crank

About Justin Crank

Mechanical engineer with over 20 years of experience in medical device R&D and a…

Experience

1. Principal Mechanical Design Engineer

   Medtronic

   Oct 2014 — Present

   Leading technical team (as R&D Core Team member) in developing sets of devices intended for long-term use in an extracorporeal life support circuit o Assisted with project and resource planning, wrote design development plan, and optimized R&D activities by making educated trades of project risk for a tighter schedule and budget o Developed and selected concepts via customer and business input o Generated design inputs, clinically-relevant product requirements, and design specs; assisted with DFMECA o Coached junior engineers with respect to design studies, drawings (content of specifications as well as level – detailed vs. black box), and test methods Project Leader/Lead R&D Engineer of cross-functional team to develop a DHF and obtain 510(k) for a legacy user-configured, kit-like product (tubing packs) and many of the devices that go into them o Proposed design control improvements to Quality System for custom tubing packs; one aspect implemented o Mined and eliminated DV gaps on 275+ devices (out of 500+ devices) and packaging provided in tubing packs through a combination of engineering rationales to leverage existing DV data, obsolescence, re-design, and testing o Conducted and documented design study for barbed tubing connections employing a combination of analytical, empirical, and statistical tools including video to look at mechanisms of deformation and regression o Developed junior engineers with respect to writing biocompatibility assessments, managing DV builds, and writing DV reports o Received two Quality Begins With Me awards Supported post-market R&D engineering activities for oxygenators, cardiotomy venous reservoirs, and tubing pack components, including: o Studies to elucidate root causes, evaluate performance, and improve design specs and associated test methods o R&D support for molding process validations of large, complex parts o R&D support for packaging DVs for tubing packs

Skills

• Design of Experiments
• Dmaic
• 21 Cfr
• Finite Element Analysis
• Injection Molding
• Gd
• Root Cause Analysis
• Minitab
• R&D
• Capa
• Iso 14971
• Fmea
• Manufacturing
• Medical Devices
• Iso 13485
• Design for Manufacturing
• Solidworks
• Gage R&R
• Validation
• Labview
• Catheters
• Pro Engineer
• Biomedical Engineering
• Quality System
• Spc
• Product Design
• Research and Development (R&D)
• Design Control
• Six Sigma
• Product Development
• Biomaterials
• Testing
• Failure Analysis
• V
• Fda
• Manufacturing Engineering
• Medical Device R