Telecommute Senior Operations Systems Engineer

Location: Nationwide

Compensation: To Be Discussed

Staff Reviewed: Wed, Apr 21, 2021

This job expires in: 13 days

Job Category: Information Technology

Remote Level: 100% Remote

Employer Type: Employer

Career Level: Experienced

Job Summary

A technology company that provides a regulated digital health platform to biopharma and Medtech companies has an open position for a Telecommute Senior Operations Systems Engineer.

Must be able to:

  • Lead definition of requirements for software-based medical devices, covering functional and non-functional requirements
  • Work closely with product management to interpret customer, business, and complianceneeds to define technical requirements
  • Identify essential and critical requirements, and effectively trace requirements to design and test cases

Applicants must meet the following qualifications:

  • 7+ years of software-based medical device systems engineering experience
  • Demonstrated expertise in FDA design control requirements (21 CFR 820.30) as applied to medical device software & device regulations
  • Experience in working in an environment following Agile methodology
  • Experience leading nearshore and/or offshore development partners
  • Demonstrated applied expertise with medical device risk analysis process
  • Experience providing technical leadership

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