Miguel Ballesteros
Summary
Dynamic and results-driven Mechanical Engineer with extensive experience in the medical device industry, with experience in extrusion processes and tooling design, RF welding processes, ultrasonic welding processes, packaging process. Engineering professional with strong focus on team collaboration and achieving results. Skilled in project management, process optimization, and technical leadership. Adept at adapting to changing needs, ensuring reliability and fostering high-performance culture. Known for strategic thinking, problem-solving, and effective communication.
Overview
38
38
years of professional experience
Work History
Engineering Manager
Command Medical Products LLC
03.2023 - Current
- Provide leadership and day to day direction to the Engineering workforce while also functioning as the project engineer on some projects
- Supports attainment of production/manufacturing goals so that the company is successful in meeting business and performance objectives
- Oversees the development and implementation of manufacturing processes to maintain proper product functionality as well as cost efficiency
- Ensures the engineering team and other manufacturing departments work together cohesively
- Responsible for the development of equipment to aid in the manufacturing process
- Performs functions to provide engineering support to manufacturing, quality and sales operations for assigned products
- Led cross-functional teams for successful product development, ensuring timely delivery and adherence to specifications.
- Enhanced overall team productivity with continuous training and mentoring of junior engineers.
- Reviewed technical documentation for accuracy, ensuring compliance with industry standards and regulations.
- Managed risk assessments during project planning phases, proactively mitigating potential issues before they arose during execution stages.
- Coordinated with sales and marketing teams to identify client needs and develop customized engineering solutions.
- Presented progress reports to executive leadership, demonstrating success in meeting project milestones on time and within budget constraints.
- Coordinated selection of manufacturing methods, fabrication, and operation of product designs.
NPD Principal Manufacturing Engineer
Command Medical Products
03.2021 - 03.2023
- Responsible for developing, implementing, and optimizing processes
- Testing and designing tooling and fixtures for products
- Improve quality and ensure compliance with regulations
- Implement advanced manufacturing techniques to streamline production processes
- Lead the development and optimization of manufacturing processes to reduce waste, improve quality, and enhance efficiency
- Develop product testing plans and protocols, and set up and run process qualifications
- Identify and implement programs to drive down cost
- Provide guidance to engineering regarding design concepts and specification requirements
- Ensure processes and procedures follow regulations
Engineer Team Leader
Command Medical Products
01.2018 - 01.2021
- Coordinates and leads a team of engineer staff to cover various areas of responsibility in the Engineering department
- All functions related to the Manufacturing Engineer position
Manufacturing Engineer
Command Medical Products
10.2012 - 12.2018
- Company Overview: Nicaragua
- Provide engineering support to internal manufacturing, quality and sales operations for assigned projects
- Provide research and development support for all assigned processes, present research as needed to clients
- Exercise considerable judgment to define manufacturing requirements and processes using lean manufacturing concepts
- Guide and develop engineers by precedent and within the limits of all established procedures and regulatory requirements
- Analyze product, customer, and regulatory requirements to determine tools, fixtures and equipment requirements for assigned projects
- Plan sequence of operations and develop line layouts
- Review potential product modifications and consult with customers, suppliers, and others to determine the best approach
- Build prototypes and ensure product meets customer's requirements and expectations
- Develop quantitative parameters for quality inspection and testing as required per customer and regulatory quality requirements
- Determine safety limits of production equipment and set appropriate stops
- Design experiments to determine parameters for processes
- Develop and execute validation protocols
- Write manufacturing procedures and necessary set up forms for process such as Ultrasonic welding, RF welding, Laser welding, Bonding (solvent and adhesive)
- Investigate equipment or process problems, devise methods of repair, and make adjustments or direct related efforts of others
- Function as internal expert on assigned processes
- Investigate process improvements/alternatives
- Recommend and report approach and viability
- Nicaragua
Manufacturing Engineer
Command Medical Products
10.2008 - 03.2012
- Company Overview: Nicaragua
- Provide engineering support to internal manufacturing, quality and sales operations for assigned projects
- Provide research and development support for all assigned processes, present research as needed to clients
- Exercise considerable judgment to define manufacturing requirements and processes using lean manufacturing concepts
- Guide and develop engineers by precedent and within the limits of all established procedures and regulatory requirements
- Analyze product, customer, and regulatory requirements to determine tools, fixtures and equipment requirements for assigned projects
- Plan sequence of operations and develop line layouts
- Responsible for the operation and maintenance of all equipment in the plant; HVAC system, Extruder system, ultrasonic welder, RF welder, packaging equipment, and various minor assembly systems
- Nicaragua
Teacher
National University of Engineering
04.1990 - 03.2012
- Company Overview: Nicaragua
- Teach undergraduate and graduate Mechanical Engineer courses
- Lead university projects in the Mechanical Engineering department
- Vice director of the Metrology department
- Nicaragua
Extrusion Operator
Command Medical Products
04.2009 - 03.2011
- Company Overview: Nicaragua
- Besides performing all duties as Manufacturing Engineer, operated the extrusion system (extruder, vacuum sizing tank, cooling tank, and puller/cutter)
- Extruding PVC medical tubing for several applications
- Nicaragua
Operation Manager
Air and Energy Construction S.A.
04.2006 - 09.2008
- Manage all operations for the design and construction of Air Conditioning Projects
Maintenance Supervisor
American Embassy Nicaragua
03.2001 - 04.2006
- Manage all operations for the maintenance of American Embassy building and annexes
Project Manager
TDEC (Enron)
01.1997 - 01.1998
- Manage the installation of 53 km of high-tension electrical line
- Responsible for 350 employees
Assistant Teacher
National University of Engineering
01.1987 - 03.1990
- Company Overview: Nicaragua
- Teach undergraduate and graduate Mechanical Engineer courses
- Nicaragua
Education
Master of Science -
Carl von Ozzietsky University of Oldenburg
01.1997
Master in Mechanical Engineering -
Stevens Institute of Technology
01.1993
Skills
- Word
- Excel
- Project
- Solid Works
- Minitab
- Visual
- Leadership skills
- Root Cause Analysis
- Lean Manufacturing Techniques
- Budget coordination
- Manufacturing
- Quality control implementation
- Budgeting & estimating
Languages
English
Full Professional
Spanish
Native or Bilingual
Timeline
Engineering Manager
Command Medical Products LLC
03.2023 - Current
NPD Principal Manufacturing Engineer
Command Medical Products
03.2021 - 03.2023
Engineer Team Leader
Command Medical Products
01.2018 - 01.2021
Manufacturing Engineer
Command Medical Products
10.2012 - 12.2018
Extrusion Operator
Command Medical Products
04.2009 - 03.2011
Manufacturing Engineer
Command Medical Products
10.2008 - 03.2012
Operation Manager
Air and Energy Construction S.A.
04.2006 - 09.2008
Maintenance Supervisor
American Embassy Nicaragua
03.2001 - 04.2006
Project Manager
TDEC (Enron)
01.1997 - 01.1998
Teacher
National University of Engineering
04.1990 - 03.2012
Assistant Teacher
National University of Engineering
01.1987 - 03.1990
Master in Mechanical Engineering -
Stevens Institute of Technology
Master of Science -
Carl von Ozzietsky University of Oldenburg
Similar Profiles
Cheryl MyersCheryl Myers
Accounting Manager at Prism Medical Products, LLC,Accounting Manager at Prism Medical Products, LLC,
Matthew ShealyMatthew Shealy
Account Representative at IZI Medical Products LLC.Account Representative at IZI Medical Products LLC.
Jofa MwakisegeJofa Mwakisege
Health Physics Consultant at Medical Readiness Command Europe (MRC, EUR)Health Physics Consultant at Medical Readiness Command Europe (MRC, EUR)