Process Development Engineer I

Location: St. Paul, MN

Description

Minnetronix Medical is a preferred partner in the development, manufacturing and commercialization of complex medical technologies. We are curious, persistent and resilient. We bring ideas, identify gaps and provide a unique ability to see and deliver possibilities. We are one company, focused in several areas, and united by a singular purpose—deliver results for our customers to improve outcomes for clinicians and patients worldwide. 

Job Summary:

This Process Development Engineer I will work cross functionally and lead the transfer of medical devices and respective processes into commercial manufacturing. A Process Development I is responsible for Introduction of new products and processes. Their responsibilities include: new product introduction, Identification and development of new manufacturing processes, pilot manufacturing, production cell layout, supplier development and selection, Manufacturing documentation, issue tracking and resolution, and continuous improvement.

 Job Duties and Responsibilities:

  • Create and maintain production documentation such as build of materials, assembly and test procedures, part drawings, and engineering change orders.
  • Address all quality documentation needs for the product line and work with QA to address any quality issues or concerns.
  • Execute process validation efforts IQ/OQ/PQ
  • Execute and perform test method validations such as Gage R&R
  • Knowledge of statistical tools, Six Sigma and DOE

Qualifications:

  • Bachelor’s degree in an engineering, technical or scientific discipline.
  • 0 to 2 years manufacturing or product development engineering experience in electronic-based manufacturing environment. Medical device preferred.
  • Experience with regulated environments such as FDA QSR’s, ISO13485 for medical devices and ISO 9001:2000 preferred.
  • Electromechanical assembly experience or knowledge of injection molding of plastics experience preferred. 
  • Must be authorized to work in the United States.

Our cultural values are the pillars of our company and define how we promise to show up: Unity, Courage, Humility, and Drive. Our cultural beliefs are the key behaviors we have identified as the most critical to advance our culture, our team and our company: 

Row Together 

•   I reach across boundaries to pursue the best outcomes for patients, customers and the company. 

•   I am passionate about producing products that help people. 

•   I collaborate with others, internally and externally, to drive the best solutions across the full product life cycle: how it works, how it’s built, how it’s controlled. 

•   I value diversity of thought and perspectives. 

 

Create Tomorrow  

•   I consistently challenge my thinking to achieve our company’s Key Results. 

•   I demonstrate a positive “can do” attitude.  

•   I project confidence in the process of design/development.  

•   I embrace changes and challenges. I am creative and innovative in my approach. 

•   I challenge the status quo and continuously searches for the best solutions.

 

Own It  

•   I own problem resolution, especially when it’s hard. 

•   I am energized by challenges and the work to solve them.  

•   I take ownership/accountability in solving problems and delivering results.  

•   I have a proven track record of designing and transferring high-performing products to production. 

 

Courageous Dialogue 

•   I seek new perspective from others to improve both thinking and doing. 

•   I lead and operate with humility; demonstrating strong emotional intelligence. 

•   I build trust in a variety of relationships. 

•   I successfully use both strong written and oral communication skills. 

•   I communicate effectively with audiences across all levels, both internally and externally. 

 

EEO Statement

Minnetronix, Inc.  provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state or local laws.

This policy applies to all terms and conditions of employment, including recruiting, hiring, placement, promotion, termination, layoff, recall, transfer, leaves of absence, compensation and training. 





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