#nowhiring! Belcan Job Opportunity
Belcan is thrilled to collaborate with our client in the medical device manufacturing industry to fill the position of Software Quality Test Engineer based in Pittsburgh, PA (remote opportunity, Zip Code: 15051).
Job Details:
- Job Title: Software Quality Test Engineer
- Location: Pittsburgh, PA (remote)
- Zip Code: 15051
- Keywords: #softwarequalityjobs ; #medicaldevicejobs ; #productengineerngjobs
Job Duties:
- 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 comply with regulatory standards and guidance such as
- FDA Design Controls CFR 820.30
- IEC 62304 – Software in a Medical Device
- IEC 82304 – Software as a Medical Device
- IEC 14971 – Risk Management
- ISO 13485 – Quality Management Systems
- 2017/745 – European Union Medical Device Regulation (EU MDR)
- Various FDA guidance including Pre-market submission guidelines, General Principles of Software Validation, Off The Shelf (OTS a.k.a SOUP) software use, Software as a Medical Device: Clinical Evaluation
- Conducts evaluation of software engineering activities in medical device development, covering requirements, software risk analysis, design, development, documentation, integration, verification, validation, and release to deliver safe, secure, and effective medical devices
Qualifications:
- 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
- Quality Management System – ISO 13485
- SiMD – IEC 62304
- SaMD – IEC 82304
- FDA 21 CFR 820.30
- 2017/745 – European Union Medical Device Regulation (EU MDR)
- Minimum of 2 years or more of experience in applying industry standards for medical devices
Belcan is a global supplier of engineering, technical recruiting, and IT services to customers in the aerospace, industrial, and government sectors. We take 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.
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