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
