Kforce Inc · 2 days ago
Mid-level Medical Device Software Design Quality Engineer
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Responsibilities
Medical Device Software Quality Engineer will work with software teams, RA, and NPD teams to ensure that the software projects are meeting regulations and quality standards
Take ownership of software projects for regulatory compliance and champion for process excellence by driving their teams towards conformance at every stage of development
Handle the Design Control process from beginning to end - will handle all 5 steps
Creates and reviews various software lifecycle project deliverables based on procedural requirements
Performs risk analysis and is responsible for risk management activities determines, evaluates, and documents software risks from product design to post-launch
Provides traceability analysis and traceability reports to ensure project requirements have been met
Participates on the Software Review Board (SRB) to evaluate and disposition software anomalies
Work with software teams, RA, NPD teams as well as other teams
Review and approve CO's as well as provides quality input to support closure (QMS updates, Procedural changes, etc.)
Provides quality input to Complaint, FA, CAPA investigations and executes corrective actions when applicable
Qualification
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Required
BS degree in Engineering, Biotechnology, or Computer Sciences or related field or equivalent combination of education and years of applicable experience
At least 2-4+ years of experience acting as a Medical Device Quality Engineer on software projects and guiding cross-functional teams towards compliance in an FDA-regulated industry
Strong working experience in Risk Analysis and Risk Management processes
Experience with the FDA Design Control process is required; Must know at least 3 to 5 steps of the design control process
Experience with product launch and product planning is important
Working knowledge of federal and other regulations including QSRs, ISO 14971, IEC 62304 are required
Skilled at promoting team cooperation and a commitment to team success
A strong understanding of the Software Development Lifecycle (SDLC)
Preferred
Knowledge of mobile app technologies is a plus but not required
Benefits
Medical/dental/vision insurance
HSA
FSA
401(k)
Life insurance
Disability insurance
ADD insurance
Paid time off for salaried personnel
Company
Kforce Inc
Kforce is a solutions firm specializing in technology and other professional staffing services.
H1B Sponsorship
Kforce Inc has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Trends of Total Sponsorships
2023 (604)
2022 (772)
2021 (1207)
2020 (914)
Funding
Current Stage
Public CompanyTotal Funding
unknown2014-06-08Acquired· by Beecken Petty O'Keefe & Company
1995-08-25IPO· nyse:KFRC
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