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Manufacturing Engineer I

Richardson, TX, USA Req #440
Tuesday, June 22, 2021

ABOUT INOGEN Inogen was founded in 2001 to improve quality of life and increase freedom and independence for oxygen therapy users. Inogen is innovation in oxygen therapy. The Inogen mission is to improve freedom and independence for oxygen therapy patients through innovative products and services. Inogen is a manufacturer and Accredited Homecare Provider.

Inogen is focused on quality care, continuous improvement, and outstanding customer satisfaction. We are a stable, USA based company dedicated to providing an exciting and rewarding career to our employees. We completed a successful Initial Public Offering on the NASDAQ in 2014 and have demonstrated substantial growth over the last five years. Our work environment is casual yet high performing, and we are looking for seriously talented, motivated, and fast-paced professionals to join our team.

Job Summary:

The Manufacturing Engineer is responsible for ensuring that Inogen's manufacturing operations are efficient and error free. To achieve this goal, the Manufacturing Engineer must ensure that product designs are manufacturable, manufacturing processes are capable of achieving DPMO goals, and that the manufacturing line is adequately supported with Engineering resources. The Manufacturing Engineer will also coordinate and lead the release of new products and revisions to products from design into manufacturing.

 

Responsibilities (Specific tasks, duties, essential functions of the job)

Manufacturing Engineer I

  • Responsible for maintenance of product documentation, including: system BOMS/drawings, packaging BOMS/drawings, configuration management, deviations, manufacturing validations, and change control.
  • Design for manufacturability review and participation
  • Manufacturing process validations including IQ/OQ/PQ
  • Manufacturing documentation generation and maintenance including manufacturing procedures, quality procedures, and equipment evaluations
  • Responsible for design control activities associated with release to manufacturing
  • Training of operators and other manufacturing personnel
  • Maintain availability for immediate response to production line issues
  • Maintain regular and punctual attendance.
  • Comply with all company policies and procedures.
  • Assist with any other duties as assigned.

Manufacturing Engineer II

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

  • New product introduction, including manufacturing process development, line layouts, and validations including IQ/OQ/PQ.
  • Oversight and management of manufacturing documentation and maintenance including manufacturing procedures, quality procedures, and equipment evaluations.
  • Where necessary, interface with vendors to resolve quality issues.
  • Improve manufacturing efficiency by analyzing cycle times, line layouts, manufacturing procedures, and identifying and implementing improvements.
  • Work with test fixture engineers to develop fixtures and equipment to increase production line efficiency.
  • Interface with contract manufacturers to facilitate change management, as required.
  • Assist with the field service repair program, including BOM updates, procedure updates, and software revision updates, as required.

Manufacturing Engineer III

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

  • Development and release of manufacturing related verification protocols
  • Documentation of IQ/OQ/PQ activities by completion and release of test reports
  • Project management / Lead Engineer for production transfer activities between facilities and/or contract manufacturers
  • Manufacturing Engineering representation on cross-functional projects, as assigned, including enterprise level projects
  • Train and mentor lower level engineers
  • Support internal and external audits for process control, validations, and equipment validations

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.
  • Knowledge of FDA GMP and ISO quality systems.
  • Must have a passion for product quality and excellence.
  • Must have interpersonal skills appropriate for interacting with engineering and manufacturing personnel.

 

Qualifications (Experience and Education)

 

Level I

Manufacturing Engineer I

  • Bachelor’s degree in Mechanical, Industrial, Engineering or related Scientific discipline, required. 
  • 1-3 years of experience in Manufacturing Engineering, required.
  • Medical device manufacturing experience, preferred.
  • Intermediate knowledge/proficiency in Microsoft Office, Solidworks Composer and EPDMpreferred.
  • 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 of experience in Manufacturing Engineering, required.
  • 2+ years of medical device manufacturing, preferred
  • Intermediate knowledge/proficiency in Microsoft Office, Solidworks Composer and EPDMrequired.
  • 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 of experience in Manufacturing Engineering, required.
  • 3+ years of medical device manufacturing, preferred.
  • Intermediate knowledge/proficiency in Microsoft Office, Solidworks Composer and EPDMrequired.
  • 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.

 

We thank all applicants in advance for their interest in the position. However, only those selected for an interview will be contacted.

Inogen is an equal opportunity employer.  We evaluate qualified applicants without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, veteran status, and other legally
protected characteristics. The EEO is the Law poster and its supplement are available here: http://www.dol.gov/ofccp/regs/compliance/posters/ofccpost.htm;
http://www.dol.gov/ofccp/regs/compliance/posters/pdf/OFCCP_EEO_Supplement_Final_JRF_QA_508c.pdf

The pay transparency policy is available here: http://www.dol.gov/ofccp/pdf/EO13665_PrescribedNondiscriminationPostingLanguage_JRFQA508c.pdf.


Inogen is committed to working with and providing reasonable accommodations to individuals with disabilities.  If you need a reasonable accommodation because of a disability for any part of the employment process, please send an e-mail to recruiting@inogen.net or call (972) 616-5668 and let us know the nature of your request and your contact information.

Other details

  • Job Family Manufacturing Engineer
  • Job Function Individual Contributor
  • Pay Type Salary
  • Employment Indicator Insider
  • Required Education Bachelor’s Degree
Location on Google Maps
  • Richardson, TX, USA