Michael Junk, Mba Email & Phone Number

Littleton, CO, US

Lakewood, Colorado, US

Lead Sustaining Engineer responsible for multiple released medical devices that were deployed in 48 countries around the worldWorked with our regulatory department to provide engineering evidence of compliance for EUMDR in the European market which included showing compliance with ISO 14971, 15223-1, and 10993.Leading effort to formalize engineering data.

Lakewood, Colorado, US

Mechanical Engineering lead on CAPA project to address customer complaints in the field which required extensive troubleshooting and system redesign which resulted in a reduction of customer complaints of 88%Worked with exterior labs to test packaging and medical device systems to the ISTA 2B standardParticipated in Kepner-Tregoe root cause analysis.

Boston, MA, US

• Lead Manufacturing Engineer on a successful cross functional team tasked with transferring refurbishment process from Hino, Japan to Golden, CO. Processes included soldering, torque specifications and epoxy bonding.
• Oversaw and participated in multiple Lean Action Work Outs to aid in visual management, single piece flow, and efficiency.
• Worked with international suppliers to work on quality and delivery issues.
• Completed projects in Q3 of 2016 that brought over $250k in savings for the company related to expanded harvest capacity and reduced workload for operators.
• Generated >30 Manufacturing Work Instruction used by >100 international and domestic technicians.
• Led site non-conformance and CAPA closures including more difficult projects that were reassigned to me to ensure timely closure.

Trelleborg, Sweden, SE

• Initiated lean manufacturing initiatives intended to better understand internal costs and increase efficiency.
• Introduced new equipment which increased efficiency in the plant while also improving quality.
• Worked closely with Design and Product Engineers to ensure products could be produced in a repeatable fashion.
• Worked with the prototyping branch of the company to define design parameters and tooling to move prototype parts through the plant efficiently and cost effectively.
• Initiated time studies to design strategies and Standard Work used to meet Takt Time.
• Built quote tool to define process and material costs to achieve more accurate prices for products, saving $500k/yr.

• Lead designer on a project to create a plastic enclosure to surround a wireless sensing module from initial design phase through to bringing the product to market.
• Worked extensively with SLA and cast parts manufacturers.
• Conducted testing on composite sensors employing a variety of test conditions in an R&D environment.
• Created and provided support for several engineering drawings in AutoCAD employing GD&T techniques.

Master Of Business Administration - Mba

Bachelor Of Science - Bs, Engineering, Mechanical Specialty