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Manufacturing Process Engineer

Job Type: Full-Time
Category: Manufacturing
Location: Plano, TX, United States
Date Posted:

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Description

The Manufacturing Process Engineer is part of the product team that is accountable for the efficient and effective production of the assigned product. The Manufacturing Process Engineer will work with Operations, Quality, and Engineering teams to prevent and respond to product and process issues related to the manufacturing of Inogen products. In addition, the Manufacturing Process Engineer will participate in process development for new product introductions and the transferring of manufacturing lines between facilities.  

Responsibilities  

Manufacturing Process Engineer I   

  • Provide real time support for product, equipment, and training issues related to the assigned product line(s).
  • Participation and review of design for manufacturability.
  • Execute validation protocols, including Installation Qualifications (IQ), Operations Qualifications (OQ), and Performance Qualifications (PQ).
  • Manufacturing documentation generation and maintenance, including manufacturing procedures, quality procedures, equipment evaluations/specifications, and bills of material (BOMs), as required.
  • Training of operators and other manufacturing personnel.
  • Maintain availability for immediate response to production line issues.
  • Where necessary, interface with vendors to resolve quality issues.
  • Execute continuous improvement, standardization, and 5S initiatives within the assigned product line(s).
  • At minimum, perform weekly reviews of SPC data from assigned product lines to ensure that yield and quality standards are being met.
  • Perform manufacturing validations related to products and processes on assigned product line(s).
  • Work with Test Fixture Engineers and Automation Engineers to develop equipment and fixtures to increase production efficiency.
  • Maintain regular and punctual attendance.
  • Comply with all company policies and procedures.
  • Assist with any other duties as assigned.

Manufacturing Process Engineer II   

In addition to items listed for Manufacturing Process Engineer I a Manufacturing Process Engineer II may also be responsible for the following.  

  • Develop manufacturing processes independently, with review by more senior engineers.

Manufacturing Process Engineer III   

In addition to items listed for Manufacturing Process Engineer II a Manufacturing Process Engineer III may also be responsible for the following.   

  • Autonomous development of manufacturing process.

Knowledge, Skills, and Abilities   

  • Must have strong work ethic.
  • Excellent oral and written communication skills required.
  • Effective conflict resolution.
  • Analytical & problem-solving skills & ability to multi-task.
  • Solutions-oriented problem solver.
  • Excellent planning, communication and organizational skills.
  • Ability to effectively interface with different departments within the company.
  • Detail oriented with attention to product quality
  • Must have knowledge or desire to implement and utilize lean manufacturing principles.
  • Must have a passion for product quality and excellence.
  • Must have interpersonal skills appropriate for interacting with engineering and manufacturing personnel.
  • Knowledge of FDA, GMP, and ISO quality systems.
  • Experience working in an FDA and ISO 13485 environment.
  • Ability to travel up to 25%.

Qualifications (Experience and Education)  

Level I   

Manufacturing Engineer I  

· Bachelor’s degree in Mechanical, Industrial, Engineering or related Scientific discipline, required.   

· 1-3 years’ experience in medical device manufacturing, required.  

· 1+ year of manufacturing line support experience, preferred.  

· Intermediate knowledge/proficiency in Microsoft Office, and Solidworks Composer, preferred.  

· Intermediate knowledge/proficiency ISO 9001 or ISO 13485, preferred.  

· A combination of training, education and experience that is equivalent to the qualifications listed above and that provides the required knowledge, skills, and abilities.  

Level II   

Manufacturing Engineer II  

· Bachelor’s degree in Mechanical, Industrial, Engineering or related Scientific discipline, required.   

· 3-5 years’ experience in Mechanical Engineering, required.  

· 2+ years of medical device manufacturing experience, preferred.  

· Intermediate knowledge/proficiency in Microsoft Office, and Solidworks Composer, required.  

· Intermediate knowledge/proficiency ISO 9001 or ISO 13485, required.  

· A combination of training, education and experience that is equivalent to the qualifications listed above and that provides the required knowledge, skills, and abilities.  

Level III   

Manufacturing Engineer III  

· Bachelor’s degree in Mechanical, Industrial, Engineering or related Scientific discipline, required.   

· 5+ years’ experience in Mechanical Engineering, required.  

· Advanced knowledge/proficiency in Microsoft Office, and Solidworks Composer, required.  

· 2+ years of medical device manufacturing experience, preferred.  

· Advanced knowledge/proficiency ISO 9001 or ISO 13485, required.  

· A combination of training, education and experience that is equivalent to the qualifications listed above and that provides the required knowledge, skills, and abilities.  

Disclaimer   

The above statements are intended to describe the general nature and level of work being performed by people assigned to this classification. They are not intended to be construed as an exhaustive list of all responsibilities, duties and skills required of personnel so classified.  

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