REMOTE Senior Principal Design Assurance Engineer- Software

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Posted 10 days ago United States Salary undisclosed
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Job Description

REMOTE Senior Principal Design Assurance Engineer- Software

Job Title

Senior Principal Design Assurance Engineer - Software

Help the World Breathe Easier by Collaborating with Innovative Vyaire Employees Around the World

As a global leader in respiratory care, we know what we do enables, improves and extends lives. We are an energetic company with a long history of revolutionary products. We devise outstanding solutions that allow patients to lead ordinary lives. We believe the best way to create new value for our customers, is to become invaluable. We know a dynamic culture with diversity of thought makes this possible. Our colleagues are people who specialize in exceeding expectations, establishing last relationships and making it a priority to listen. We are dedicated to anticipating what's next and get it done. We thrive on contributing and making a difference.

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The Impact You'll Make in this Role

As a Sr. Principal Design Assurance Engineer - Software, you will have the opportunity to tap into your curiosity and collaborate with some of the most innovative and a diverse group of people around the world. Here, you will make an impact by:

  • Support and monitor new product development project needs in design controls for adherence to the internal quality management system and all ISO, FDA, and QSR regulations.
  • Partner with R&D to assess the technical aspects of the product design and support the solutions.
  • Support software changes consistent with internal procedures compliant with IEC 62304 Software Development Life Cycle.
  • Provide Design assurance engineering leadership in software development process per IEC 62304.
  • Partner with IT product security and Software development teams to establish robust SDLC and Cybersecurity Processes.
  • Manage and coordinate risk management activities. Create/update risk management plan, Hazard analysis, RBA and risk management report. Support and monitor new product development project needs in design controls for adherence to the internal quality management system and all ISO, FDA, and QSR regulations to include ISO 13485, 21CFR820.30, ISO 14971 and IEC 60601
  • Support pre & post-production design assurance/quality engineering activities as they relate to product lifecycle development.
  • Review test plan/protocols and final reports for completeness and accuracy.
  • Complete assigned tasks on schedule and identify and propose resolution for issues that may affect the timeline for remediation activities.
  • Support CAPA investigations, reviews, approvals, and/or CAPA plan implementations as required.
  • Support audits and quality function initiatives.
  • Your Skills and Expertise

    To set you up for success in this role from day one, Vyaire is looking for candidates who must have the following qualifications:

  • Bachelor's degree or higher in Engineering from an accredited institution
  • Minimum 8-10 years of experience in a electro-mechanical software driven medical device industry working as quality and design assurance role.
  • Demonstrated and impactful experience in product development, software validation (device & quality system support), test method validation, Statistics, Risk Management Tools and Process Control & Monitoring (SPC).
  • Extensive experience in SDLC process per IEC 62304.
  • Additional qualifications that could help you succeed even further in this role include:

  • Master's degree in Engineering is preferred.
  • Six Sigma green belt
  • Strong interpersonal skills with the aptitude to be a team player; setting a professional tone and establishing a cooperative partnership within the department and other areas of the company.
  • Demonstrated and impactful strong project management and people leadership skills required.
  • Travel: May include up to 20% domestic/international

    Relocation Assistance: May be authorized

    Benefit elections are among the most meaningful choices that we make for ourselves and our family. That is why Vyaire offers a comprehensive benefits package that includes various options to meet the diverse needs of our employees.

    Must be legally authorized to work in country of employment without sponsorship for employment visa status (e.g., H1B status). (Must approve with your HRBP if you wish to remove this)

    Chicago, IL, Dallas, TX, Houston, TX, Irvine, CA, Los Angeles, CA, San Diego, CA, Seattle, WAFull time