Medical Device Software Quality Engineer

4 weeks ago

Pittsburgh PA United States StarsHR, Inc. Full time
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.*_

Job Type: Contract

Pay: $58.07 - $70.01 per hour

Expected hours: 40 per week

Benefits:
* 401(k) matching
* Dental insurance
* Health insurance
* Life insurance
* Vision insurance
Experience level:
* 5 years
Schedule:
* 8 hour shift

Work Location: Hybrid remote in Pittsburgh, PA 15238

  • Medical Device Software Quality Engineer

    4 weeks ago

    Pittsburgh, United States StarsHR, Inc. Full time

    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,...

  • Medical Device Software Quality Engineer

    2 weeks ago

    Pittsburgh, Pennsylvania, United States StarsHR Full time

    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,...

  • Medical Device Software Quality Engineer

    4 weeks ago

    Pittsburgh, United States StarsHR, Inc. Full time

    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,...

  • Principal Fullstack Software Engineer

    4 weeks ago

    Pittsburgh, United States Motion Recruitment Partners LLC Full time

    Company Overview: Join a pioneering medical device company, dedicated to leveraging technology to save lives and improve patient care. Our company operates at the forefront of innovation, developing cutting-edge medical devices that revolutionize healthcare delivery. By combining expertise in software engineering with a commitment to advancing medical...

  • Test Engineer with Medical Devices

    7 hours ago

    Pittsburgh, United States Ztek Consulting Full time

    Job Role: Test Engineer with Medical DevicesLocation: Pittsburgh, Pennsylvania, United StatesJob Description:A. Requirement Analysis and Co-ordination:1. Requirement gathering and analysis with Product owner, QA lead and Programming lead.2. Convey the software testing requirements to the offshore team.3. Co-ordinate the testing deliverables in between...

  • Senior Software Engineer

    4 weeks ago

    Pittsburgh, United States Macpower Digital Assets Edge Private Limited (MDA Edge) Full time

    Summary: Seeking a Senior Systems Verification and Validation (V&V) Engineer. The selected candidate will work as a V&V Lead to coordinate all V&V activities necessary to support the release of new and updated medical devices. Focus will be assessing and testing the requirements of electromechanical medical devices at the part, sub-system, and system...

  • Embedded Software Engineer

    4 weeks ago

    Pittsburgh, United States Agilite Full time

    Job DescriptionJob DescriptionSalary: JOB DESCRIPTIONOur client is the world leader in pharmacy robotics, and our robotic IV automation system empowers pharmacists and technicians with tools to improve dose accuracy and make IV pharmacy compounding safer while reducing costs and enabling compliance. As a Staff Embedded Software Engineer you will play a lead...

  • Embedded Software Engineer

    4 weeks ago

    Pittsburgh, United States Agilite Full time

    Job DescriptionJob DescriptionSalary: JOB DESCRIPTIONOur client is the world leader in pharmacy robotics, and our robotic IV automation system empowers pharmacists and technicians with tools to improve dose accuracy and make IV pharmacy compounding safer while reducing costs and enabling compliance.As a Staff Embedded Software Engineer you will play a lead...

  • Principal Fullstack Software Engineer

    2 weeks ago

    Pittsburgh, Pennsylvania, United States Motion Recruitment Partners LLC Full time

    Company Overview:Join a pioneering medical device company, dedicated to leveraging technology to save lives and improve patient care. Our company operates at the forefront of innovation, developing cutting-edge medical devices that revolutionize healthcare delivery. By combining expertise in software engineering with a commitment to advancing medical...

  • Associate Embedded Software Engineer

    4 weeks ago

    Pittsburgh, United States Software Engineering Institute Full time

    About the role Are you an engineer who enjoys a challenge? Are you excited about working for an FFRDC focused on areas critical to national security? Do you want to join a collaborative team that develops and uses best-in-class tools to enable end-to-end software development? If so, we want you for our team, where you'll be part of an exciting and impactful...

  • Associate Embedded Software Engineer

    3 weeks ago

    Pittsburgh, United States Software Engineering Institute Full time

    About the role Are you an engineer who enjoys a challenge? Are you excited about working for an FFRDC focused on areas critical to national security? Do you want to join a collaborative team that develops and uses best-in-class tools to enable end-to-end software development? If so, we want you for our team, where you'll be part of an exciting and impactful...

  • Director, Software Engineering

    2 weeks ago

    Pittsburgh, United States Omnicell Full time

    Director, Software Engineering – Hybrid Omnicell is the world leader in pharmacy robotics, and our robotic IV automation system empowers pharmacists and technicians with tools to improve dose accuracy and make IV pharmacy compounding safer while reducing costs and enabling compliance. As an Omnicell Software Embedded Engineering Director, you will lead the...

  • Director, Embedded Software Engineering

    3 weeks ago

    Pittsburgh, United States The Ladders Full time

    Director, Embedded Software Engineering - Hybrid Our client is the world leader in pharmacy robotics, and our robotic IV automation system empowers pharmacists and technicians with tools to improve dose accuracy and make IV pharmacy compounding safer while reducing costs and enabling compliance. As Software Embedded Engineering Director, you will lead the...

  • Director, Embedded Software Engineering

    4 weeks ago

    Pittsburgh, United States Agilite Full time

    Job DescriptionJob DescriptionSalary: Director, Embedded Software Engineering – HybridOur client is the world leader in pharmacy robotics, and our robotic IV automation system empowers pharmacists and technicians with tools to improve dose accuracy and make IV pharmacy compounding safer while reducing costs and enabling compliance.As Software Embedded...

  • Medical Device System Architect

    5 days ago

    Cincinnati, OH, United States Guerbet Full time

    At Guerbet, we build lasting relationships so that to enable people to live better. This is Our Purpose.We are a global leader in medical imaging, offering an extensive portfolio of pharmaceuticals, medical devices, digital and AI solutions, for diagnostic and interventional imaging. As a pioneer in the field of contrast products since the last 95 years ,we...

  • Director, Embedded Software Engineering

    2 weeks ago

    Pittsburgh, Pennsylvania, United States Omnicell Full time

    Job Description Director, Software Engineering - Hybrid Omnicell is the world leader in pharmacy robotics, and our robotic IV automation system empowers pharmacists and technicians with tools to improve dose accuracy and make IV pharmacy compounding safer while reducing costs and enabling compliance. As an Omnicell Software Embedded Engineering Director, you...

  • Software Engineer

    4 weeks ago

    Pittsburgh, Pennsylvania, United States ZOLL Medical Corporation Full time

    DataAt ZOLL, we're passionate about improving patient outcomes and helping save lives.We provide innovative technologies that make a meaningful difference in people's lives. Our medical devices, software and related services are used worldwide to diagnose and treat patients suffering from serious cardiopulmonary and respiratory conditions.ZOLL Data Systems,...

  • Senior Software Engineer

    2 weeks ago

    Pittsburgh, United States Bayer U.S. LLC Full time

    Bayer U.S. LLC seeks a Senior Software Engineer to work in Indianola, PA, on complex medical device development projects as a member of Software Assurance & Operations group. recblid b11g4g9g7f3k006rq2ydkkwoif0jan

  • Junior Software Engineer Analyst

    4 weeks ago

    Pittsburgh, United States Software Engineering Institute Full time

    What We Do The Software Engineering Institute (SEI) at Carnegie Mellon University helps advance software engineering principles and practices and serves as a national resource in software engineering, computer security, and process improvement. The SEI works closely with defense and government organizations, industry, and academia to continually improve...

  • Sr. Embedded Software Engineer

    4 weeks ago

    Pittsburgh, United States Smith & Nephew Full time

    We are seeking an experienced Build and Release Engineer to join our team. As a Build and Release Engineer, you will be responsible for the creation and maintenance of build and deployment systems for our software products. This includes managing the build pipeline and ensuring that our products are built and deployed in a consistent and reliable manner. You...