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Careers

Our team is growing! Learn more about our current opportunities below.

Quality Engineer
Responsibilities:

Work as a quality consultant for medical device companies and various types of devices, diagnostics, and SaMD.

Provide Quality Engineering support for the design, risk analysis, and verification/validation of new medical device products.

Work closely with startup medical device companies and products to ensure all aspects of the design history file, technical file, and risk management file are completed during the development process.

Assist product development teams during development of new devices and software. Responsible for implementation of product quality plans, verification/validation protocols and reports.

Maintain quality system processes and procedures to ensure compliance to all domestic and international standards or requirements. Keep current on all applicable best practices and statutory regulations governing the design, procurement, manufacture, marketing, and distribution of medical devices.

Conduct and support internal and external audits for clients to maintain compliance with the FDA, ISO 13485, CE Mark (MDR), MDSAP.

Support post-market activities including CAPA, non-conformances, complaint handling and investigation, supplier assessment, adverse event reporting, and other activities.

Candidates are able to work remotely from home with optional travel as needed.

Qualifications:

  • Bachelor’s degree or equivalent in Engineering or related field
  • 1-5+ years’ of industry experience
  • Strong knowledge of quality tools used in the industry
  • Analytical and quantitative approach to problem solving
  • Strong communications skills

Benefits:

  • Collaborative team dedicated to working to support medical device innovation and compliance.
  • Remote working and flexible hours
  • PTO
  • Health and Dental Insurance
  • 401k
  • Employee training and certifications provided
APPLY
Software Quality Engineer
Responsibilities:

Work as a quality consultant for medical device companies and various types of devices, diagnostics, and SaMD.

Provide Software Quality Engineering support for the design, risk analysis, and verification/validation of new medical device software products.

Strong working knowledge of IEC 62304, AAMI TIR45, Agile methodology, software design and testing.

Work closely with startup medical device companies and products to ensure all aspects of the software design file and risk management file are completed during the development process.

Assist product development teams during development of new devices and software to ensure proper documentation and records are created.

Responsible for implementation of product quality plans, verification/validation protocols and reports.

Maintain quality system processes and procedures to ensure compliance to all domestic and international standards or requirements.

Qualifications:

  • Bachelor’s degree or equivalent in Engineering or related field
  • 1-3+ years’ of industry experience
  • Strong knowledge of software development and tools used in the industry
  • Analytical and quantitative approach to problem solving
  • Strong communications skills

Benefits:

  • Collaborative team dedicated to working to support medical device innovation and compliance
  • Remote working and flexible hours
  • PTO
  • Health and Dental Insurance
  • 401k
  • Employee training and certifications provided

 
APPLY

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