Inogen, Inc.
  • Engineering/R&D
  • Richardson, TX, USA
  • Full Time

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 DESCRIPTION 

The Manufacturing Engineering Manager is responsible for ensuring that Inogen's manufacturing operations at an assigned location are efficient and error free. To achieve this goal, the Manufacturing Engineering Manager must work to continuously improve the manufacturing capabilities and results at the assigned location. This position must additionally ensure manufacturing processes are capable of achieving DPMO goals, and that the manufacturing line is adequately supported with Engineering resources. The Manufacturing Engineering Manager will also coordinate and lead the release of revisions to products into manufacturing. The Manufacturing Engineering Manager will lead and manage the other manufacturing engineering personnel at the assigned location to ensure all goals and objectives are achieved.

The Manufacturing Engineering Manager will have many of the same responsibilities as the Engineering Manager but will solely focus on existing products manufactured by Inogen at the assigned location.

Key Competencies:

  • Responsible for oversight and management of product documentation including packaging drawings, configuration management, deviations, manufacturing validations, labels, field service documentation, and change control
  • Manufacturing process validations including IQ/OQ/PQ
  • Oversight and management of manufacturing documentation and maintenance including manufacturing procedures, quality procedures, and equipment evaluations, and equipment calibration / maintenance
  • Responsible for design control activities associated with manufacturing process revisions and improvements
  • Leadership, management, and training of other manufacturing engineers, operators, and other manufacturing personnel.
  • Maintain availability for immediate response to production line issues.
  • Work with operations personnel to lead coordination of change control and implementation.
  • Lead pending changes meeting and process to ensure visibility of changes and continuous improvement activities.
  • Maintain regular and punctual attendance.
  • Comply with all company policies and procedures.
  • Assist with any other duties as assigned.

Do you possess these abilities?

  • Must have knowledge or desire to implement and utilize lean manufacturing principles including waste reduction, continuous improvement, standard work, and problem solving
  • Knowledge of FDA GMP and ISO quality systems.
  • Experience working in an FDA and ISO 13485 environment.
  • Attention to detail and follow through required.
  • Must have a passion for product quality and excellence.
  • Detail oriented with attention to product quality.
  • Self-motivating and capable of self-direction.
  • Good attention to detail and accurate and complete documentation.
  • Ability to lead and manage other engineers and projects.
  • Vision and desire to grow the department and its capabilities.
  • Must have strong work ethic.
  • Excellent oral and written communication skills required.
  • Analytical & problem-solving skills & ability to multi-task.
  • Solutions-oriented problem solver.
  • Must have interpersonal skills appropriate for interacting with engineering and manufacturing personnel.

Requirements:

  • Bachelor's degree in Mechanical, Industrial, or related Engineering or Scientific field, required; Master's degree, preferred.
  • 7+ years of experience in medical device manufacturing, required
  • 2 years' in a project management role or supervisory/lead role, required
  • Advance knowledge/proficiency in Microsoft Office and Solidworks Composer, required.
  • Advance knowledge/proficiency ISO 13485, required.
  • Expertise in oxygen concentrator design and manufacturing, 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.

WHY INOGEN Inogen is a dynamic company that is not only focused on quality care of patients, but is also committed to being a top employer.  Each of Inogen' s offices have a casual culture that supports employees being responsible and developing professionals.

We offer competitive salaries and a robust benefit package:

  • Employee Stock Purchase Plan 401 (K) plan available for all employees Health, dental, vision insurance Flexible spending accounts and wellness discount program Life Insurance Long Term Disability Robust paid time off and 8 paid holidays Employee Assistance Program

See the Inogen Team in action:

https://www.youtube.com/watch?v=dKoTMeJf5J4

 

Inogen Where we go to work hard to positively impact people's lives

 

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.

 

 

Inogen, Inc.
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