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Marko Krutyholowa
Marko Krutyholowa
Principal at Concept to Commercialization
Greater Boston Area


  • Focus: Contributions are valued by peers
  • Accountability: Thoroughly contributes in all areas
  • Sense of Urgency: Consistently responds in a timely fashion
  • Team: Frequently supports and responds to peers
info

Awards earned:

1

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0

0

Level: LEVEL 02

12 month points: 40 ptsView details

Total points: 386 pts

skills
Automation 32
Strategy 16
Manufacturing 11
Medical Devices 4
Polymers 2
Electromechanical 2
FDA 2
Six Sigma
Design of Experiments
Lean Manufacturing
Validation
V&V
Product Development
Minitab
Process Engineering
CAPA
ISO 13485
R&D
Quality System
Design Control
Commercialization
Quality by Design
Combination Products
Management
Ceramics/Metals Casting Engineering
Leadership
Biomaterials
GMP
Kaizen
Cross-functional Team Leadership
Scalability
Polymer Processing
New Product Introduction
Pharmaceutical Device Combination Products
Process Scale Up
Continuous Improvement
Design For Six Sigma
Root Cause Analysis
DMAIC
Value Stream Mapping
Biomedical Engineering
Business Process Improvement
U.S. Food and Drug Administration (FDA)
Failure Mode and Effects Analysis (FMEA)
Project Management
Cross Functional Team Building
Strategic Planning
PROFILE

Summary

My career focused on the development of innovative products and processes and has spanned several industries. Successes include developing and leading high-performing engineering teams, architecting business-critical cost saving and operational strategies, designing and implementing new and novel multi-million dollar manufacturing processes, and partnering internally and externally to manage the delivery of new product launches.

Experience

Product and Process Development/Commercialization Program Managing Director

Concept to Commercial Executives

January 2017 - Present

Focused on the development of innovative products and processes that span several industries, medical device, biotech drug delivery devices, consumer products, automotive, and aerospace. Success includes developing and leading high-performing teams, architecting business-critical strategies, designing and implementing new and novel multi-million dollar manufacturing processes, and partnering internally and externally to manage the delivery of product and process development programs.

Process Engineering Manager

Markem-Imaje

October 2017 - Present

Principal

Concept to Commercialization

November 1999 - Present

Provide industry experience to business leaders in the future manufacturing , medical device, biologics, and combination device industries. Participate as discussion board member for thought leaders, phone consult for senior leaders or venture firms, and strategic program or project consultant for program managers or project leaders.

ACTIVITY