Software Device Quality Engineer in Cambridge, MA at Eliassen Group

Date Posted: 11/5/2018

Job Snapshot

  • Employee Type:
  • Location:
    Cambridge, MA
  • Job Type:
  • Experience:
    Not Specified
  • Date Posted:

Job Description

Our client is one of the oldest independent biotech companies in the world, with a commitment to innovation, excellence, and continual improvement of quality of life for people around the globe. They are currently looking for a Software Device Quality Engineer to join their dedicated team.

Responsibilities of the Software Device Quality Engineer:

  • Manage review and approval of SDLC deliverables in alignment with medical devices with software protocol
  • Review and approve plans, protocols, and reports generated as part of the software development process
  • Serve as SME in the development and revision of validation documents to ensure regulatory compliance for medical devices with software
  • Review and approve quality issues and technical matters that impact design control and risk management

Requirements of the Software Device Quality Engineer:

  • Bachelor's or Master's in Life Sciences or Software Engineering
  • Experience in computerized system validation in a regulated environment
  • Knowledge of IEC 62304, Medical Device Software, SDLC processes
  • Knowledge of FDA Quality System requirements

Keywords: Software Device Quality Engineer, FDA Quality System Requirements, Regulated, Medical Devices, SDLC, Biotechnology

Job ID: 312915

About Eliassen Group:

Eliassen Group provides strategic talent solutions to drive our clients’ innovation and business results. Leveraging nearly 30 years of success, our expertise in IT staffing, Agile consulting, creative services, managed services, and life sciences enables us to partner with our clients to execute their business strategy and scale effectively. Headquartered in Reading, MA and with offices from coast to coast, Eliassen Group offers local community presence, deep networks, as well as national reach. For more information, visit

Eliassen Group is an Equal Opportunity/Affirmative Action Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, pregnancy, sexual orientation, gender identity, national origin, age, protected veteran status, or disability status.

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