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Openings >> Manufacturing Engineer
Manufacturing Engineer
Summary
Title:Manufacturing Engineer
ID:1175
Department:Engineering
Location:Colorado Springs, CO
Description

 Position Summary:
Provide engineering support to manufacturing operation on routine basis. Develop and improve manufacturing methods, systems and processes to produce a high quality product at optimal cost. Act under general supervision of Manufacturing Engineering Team Lead on multiple assignments of moderate scope and complexity.

Essential Functions and Basic Duties:

General:
Follow all employee guidelines and Quality Systems Regulations (QSR's) as defined by CEA's practices, policies and Standard Operating Procedures (SOP's) to insure that customer requirements and FDA (or equivalent) regulations are met.

Production Support and Troubleshooting:

  • Provide engineering support to manufacturing operation on routine basis.
  • Address product related issues arising on the production floor.

Continuous Improvement and Cost Reduction:

  • Continually improve manufacturing methods/systems and process/ product improvements to optimize product performance and reduce manufacturing costs.
  • Identify and evaluate opportunities for improvement and make specific recommendations for adoption.
  • Perform cost analyses to reduce or optimize product costs.

Concurrent Engineering:

  • Support new product development or existing product line extensions/modifications by ensuring new products or manufacturing processes are designed to facilitate ease of manufacturing and to produce quality, cost effective products with optimized yields.
  • Define and generate all required documentation in support of manufacturing products and processes. These include: Engineering protocols, FMECAs, reports, manufacturing instructions and procedures.
  • Ensures compliance with GMP’s and internal protocol.
  • Uses appropriate statistical support and Design of Experiments (DOE) when developing recommendations.

Equipment and Fixturing:

  • Determine specific requirements of manufacturing operation in order to specify equipment, fixturing, and process parameters.
  • Collaborate on design with suppliers to fulfill equipment and fixturing requirements.

Qualification and Validation:

  • Develop plans to evaluate process repeatability and stability through equipment qualification and process validation. Apply appropriate statistical methodologies.

Other duties as assigned.
 

Qualifications

Education / Certifications:

  • Bachelor Degree in Engineering with a minimum of 3 years in a manufacturing or production environment..

 

Required Knowledge:

Minimum

  • Bachelor’s degree in Engineering with a minimum of 3 years in a manufacturing or production environment
  • Solid interpersonal and communication skills and ability to work in a team environment
  • Experience with CAPA’s, MRB’s, and/or NCMR’s
  • Experience with statistical analysis of Production processes
  • Current or recent experience with equipment and/or process qualifications and validations (IQ,OQ, PQ)
  • Experience writing protocols, reports and engineering change orders

Preferred

  • Advanced degree in Engineering
  • One year of medical device manufacturing or manufacturing in highly regulated environment 
  • Experience with quality standards such as ISO 13485, ISO 14971, FDA 21 CFR Part 11
  • Experience designing and conducting DOEs using MiniTab.
  • CAD skills

Great benefits offered including medical, dental, 401K and more!

Biomedical Innovations, a Nissha company, is an Equal Opportunity Employer; and considers applicants for all positions without regard to race, color, religion, creed, gender, gender identity, national origin, age, disability, marital or veteran status, sexual orientation, or any other legally protected status. In addition, Biomedical Innovations will provide reasonable accommodations for qualified individuals with disabilities.

If you need assistance with completing the online application process, please call Biomedical Innovations at (719) 591-5300.

  

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Advancement Opportunities

We believe in promoting and growing talent from within! Employees are offered opportunities to apply for open positions.

Compensation and Benefits

Specific benefits will vary by location. In general they include:

  • Competitive Financial Compensation
  • Training and Development
  • Healthcare Coverage
  • Health and Wellness Incentives
  • Disability Protection
  • Tuition Reimbursement
  • Retirement Plans
  • Service Awards

Diversity EEO Statement

Graphic Controls is an Equal Opportunity Employer. Graphic Controls considers applicants for all positions without regard to race, color, religion, creed, gender, national origin, age, disability, marital or veteran status, sexual orientation, or an other legally protected status.

Culture

For over 60 years, Graphic Controls has been a Company that values it's employees and their hard work. Employees are offered great benefits and opportunities which make coming to work everyday something to look forward to. Employee satisfaction is proven by the simple fact that our average length of service is over 15 years.