StarsHR has the following long-term contract opportunity available with our client in Pittsburgh.

Medical Device Software Quality Engineer.

This individual will be responsible for the Software Quality Management of Software in Medical Device (SiMD) of Class-2 and Class-1 medical devices, including Application software, Embedded software, Platform software, and Operating system software. They will be responsible for ensuring that the development initiatives of all medical devices comply and adhere to 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) and various FDA guidance 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. They will also be responsible for ensuring computer system validation initiatives comply and adhere to standards and guidance such as General Principles of Software Validation, Computer Software Assurance for Production and Quality System Software, FDA CFR Part 11 Compliance.

QUALIFICATIONS

• Bachelor’s degree in Computer Engineering, Electronics, or Electrical Engineering or related.

• 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 13485 o SiMD – IEC 62304 o SaMD – IEC 82304 o FDA 21 CFR 820.30 o 2017/745 – European Union Medical Device Regulation (EU MDR)

• Minimum of 2 years or more of experience in applying industry standards for medical device development as follows o General Principles of Software Validation o FDA CFR Part 11 Compliance

• Must be able to handle multiple tasks/projects and manage priorities accordingly.

• Technical writing ability – clear and concise writing easily understood by multiple audiences (auditors, peers, etc.) • Ability to work in-office and remote

Good to have:

• Familiarity with AI/ML based medical device software quality management • 2 or more years of relevant work experience in various phases of software development lifecycle including requirements, architecture, design, development, testing, release, deployment, post-launch support activities • 2 or more years of programming experience in any of the following languages C, C#, Java, React JS, Angular • Working knowledge of tools including JIRA, AWS, GitHub, Rational Quality Manager, DOORS Next Gen • Working knowledge on OS such as Windows, Linux flavors • Demonstrated ability working in a matrix/hybrid organization structure • Ability to troubleshoot and make quick knowledge and experience-guided decisions • Excellent written and oral communication • Excellent people skills, ability to partner well, good team camaraderie • Proficient with Microsoft Office tools especially MS Word, MS Excel, MS PowerPoint, MS Project, and other management tools.

StarsHR can provide benefits while contracting through our company. Sponsorship is available for well-qualified candidates. THE USE OF C2C SUBCONTRCTORS HAS BEEN STRICTLY FORBIDDEN BY OUR CLIENT. PLEASE DO NOT WASTE YOUR TIME OR OURS APPLYING IF YOU ARE NOT WILLING TO WORK ON W2.