Software Quality Engineer - Medical Devices - W2

Software Quality Engineer - Medical Devices - W2Job Number: 343158Category: SoftwareDescription: #nowhiring! Belcan is excited to work with our client in the medical device manufacturing industry in hiring a Software Quality Engineer to evaluate application, AI and platform medical device software to FDA design control and customer standards.Job Title: Software Quality Test EngineerLocation: Pittsburgh, PA (remote)Zip Code: 15051Keywords: #softwarequalityjobs ; #medicaldevicejobs ; #productengineerngjobsJob duites:

Software Quality Management of Software in Medical Device (SiMD) of Class-2 and Class-1 medical devices, including

Application software, Embedded software, Platform software, Operating system software

Software Quality Management of Software as a Medical Device (SaMD) of Class-2 and Class-1 medical devices, including

Application software, AI/ML software, Platform software including IaaS and PaaS, Cloud based software

Responsible for ensuring development initiatives of medical devices complies and adheres to regulatory standards and

guidance such as FDA Design Controls CFR 820.30, IEC 62304 - Software in a Medical Device, IEC 82304 - Software as aMedical Device, IEC 14971 - Risk Management, ISO 13485 - Quality Management Systems, 2017/745 - European UnionMedical Device Regulation (EU MDR) and various FDA guidance Pre-market submission guidelines, General Principles ofSoftware Validation, Off The Shelf (OTS a.k.a SOUP) software use, Software as a Medical Device: Clinical Evaluation

Conducts evaluation of software engineering activities of medical device development including requirements, software

risk analysis, design, development, documentation, integration, verification, validation and release to deliver medicaldevices that are safe, secure and effectiveQualifications:

Bachelor"s degree in Computer Engineering, Electronics, or Electrical Engineering

Minimum of 7 years of relevant work experience in software engineering or quality engineering in medical device development

Minimum of 2 years of relevant work experience in software quality management of Class 2 or Class 3 medical devices including Software in Medical Device (SiMD) or Software as Medical Device (SaMD)

Minimum of 2 years or more of experience in interpreting industry standards for medical device development and updating processes and procedures

o Quality Management System - ISO 13485o SiMD - IEC 62304o SaMD - IEC 82304o FDA 21 CFR 820.30o 2017/745 - European Union Medical Device Regulation (EU MDR)

Minimum of 2 years or more of experience in applying industry standards for medical device

Belcan is a global supplier of engineering, technical recruiting, and IT services to customers in the aerospace, industrial, and government sectors. Belcan engineers better outcomes through adaptive and integrated services-from jet engines, airframe, and avionics to heavy vehicles, chemical processing, and cybersecurity. Belcan takes a partnering approach to provide customer-driven solutions that are flexible, scalable, and cost-effective. Our unique capabilities have led to continuous growth and success for nearly 60 years. We are a team-driven Equal Opportunity Employer committed to workforce diversity.Location: Indianola , PAMinimum Experience (yrs): Required Education: Not SpecifiedBenefits: Return to search results Email this job to a friend (emailjobs.asp?jonum=343158) If you have previously registered with us, pleaseLog in (memberlogin.asp) to apply for this position.Logged in members may also add jobs to their job cart