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Design Quality Engineer II

Job Type: Full-Time
Category: Quality Assurance
Location: Plano, TX, United States
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Description

Job Summary:   

The Design Quality Engineer is responsible for supporting Inogen product development and sustaining engineering teams. This position plays a key technical leadership role in Inogen’s Product Development and Design Control processes. The Design Quality Engineer is responsible for engineering activities including participating in review and gap assessment of design requirements, development, execution and maintenance of risk management plans and activities, identification of applicable standards, review of component and system level specifications, test method development, test plan and protocol development for design verification and design validation activities, data review and analysis from key testing activities, participating in design reviews and process validation activities related to design transfer to manufacturing.   

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

Design Quality Engineer I  

  • Under the guidance of the Design Quality Director, participate in new product design and development process.
  • Provide effective quality engineering support for multiple projects, and balance priorities to meet both project and management expectations.
  • Apply Design for Reliability and Manufacturability tools and techniques to ensure Inogen product designs are robust, fit Inogen’s manufacturability model, and meet customer needs.
  • Collaborate with R&D, Marketing, Regulatory Affairs, Supply Chain and Manufacturing to ensure effective and robust risk management, testing, verification, validation, IQ/OQ/PQ as applicable for products and processes in the concept to market phases of product development.
  • Update job knowledge by keeping abreast of trends and developments in design quality assurance, statistical analysis, test development, ISO 13485, MDR, Health Canada, and FDA quality systems, and participating in educational opportunities.
  • Assist in developing Risk Management documents (Risk management plan, UFMEA, DFMEA)
  • Maintain regular and punctual attendance. Comply with all company policies and procedures. Assist with any other duties as assigned.

Design Quality Engineer II  

In addition to the above responsibilities, the Design Quality Engineer II may be responsible for the following:  

  • Assist in continuous improvement activities as necessary and as driven by product lifecycle management that generate Sustaining Engineering projects.
  • Assist in preparing written reports of analysis for design verification, design validation and other critical testing and evaluation activities, as required by the project or department management. Assist or maintain Design History File
  • Support internal and external audits for domestic and international suppliers as necessary.
  • Responsible for partnering with Product Development teams and Supply Chain personnel in the assessment of component and system level specifications relative to customer needs and product performance specifications.
  • Assist in the effective transition from product design to production.
  • Review manufacturing and quality processes for improvement and risk.
  • Assist in establishing Device Master Record.

Knowledge, Skills, and Abilities   

  • Experience with risk management, design verification, design validation, and process validation.
  • Ability to compile data from various sources to produce useful reports.
  • Ability to trend and verify process improvements.
  • Must have a strong work ethic.
  • Excellent oral and written communication skills required.
  • Attention to detail is required.
  • Effective conflict resolution.
  • Analytical & problem-solving skills & ability to multitask.
  • Solutions-oriented problem solver.
  • Excellent planning, communication, and organizational skills.
  • Ability to effectively interface with different departments within the company.

Qualifications (Experience and Education)  

Level I  

Design Quality Engineer I  

  • Bachelor’s degree in Engineering or related field of study, required.
  • 1-3 years’ experience in production, engineering, or design quality assurance, required. Preferably in a regulated manufacturing environment (i.e. ISO, FDA, FAA).
  • Experience in responding to compliance to FDA, MDD and ISO regulations.
  • Experience in leading Design Verification and Validation activities.
  • Experience in and process risk analysis/FMEA, specification writing, test method development, statistical analysis of quantitative and qualitative data, test report writing and medical device design reviews.
  • Six Sigma green belt, preferred.
  • Advanced knowledge/proficiency in Microsoft Office, and Oracle, required.
  • Geometric dimensioning & tolerance (GD&T) training, preferred.

Level II  

Design Quality Engineer II  

  • Bachelor’s degree in Engineering or related field of study, required.
  • 3-5 years’ experience in production, engineering, or design quality assurance, required. Preferably in a regulated manufacturing environment (i.e. ISO, FDA, FAA).
  • Experience in responding to compliance to FDA, MDD and ISO regulations.
  • Experience in leading medical device Design Verification and Validation activities.
  • Experience in and responsibility for product and process risk analysis/FMEA, specification writing, test method development, statistical analysis of quantitative and qualitative data, test report writing and medical device design reviews.
  • Six Sigma black belt, preferred.
  • Advanced knowledge/proficiency in Microsoft Office, and Oracle, required.
  • Geometric dimensioning & tolerance (GD&T) training, preferred.

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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