Principal Design Assurance, Software

Imagine how your ideas and expertise can change a patient’s life. Our Design Assurance teams help shape the development of groundbreaking technologies to ensure each stage of our innovation process is held to the highest standards of integrity and safety. You’ll bring your passion for problem solving and partner with R&D teams to influence decision-making for a product’s entire lifecycle. Your work will involve you optimizing product development to impact patients around the world with pioneering technology.

How you will make impact:

• Lead Risk Management activities (including authoring risk management documents).
• Collaborate with R&D teams to identify and generate product requirements and ensure regulatory compliance.
• Responsible for adhering to company SDLC procedures and approving development documentation.
• Collaborate with stakeholders on the Code Review process for software product.
• Review and approve SW V&V and system DV and Dval plans and reports.
• Responsible for TMV for both development and process test methods.
• Ensure early focus on manufacturability in NPI programs.
• Perform other duties and responsibilities as assigned.
  
  

• Bachelor’s degree in Computer Science, Software Engineering, Computer Engineering, Biomedical Engineering, or combination of “STEM” Majors (Science, Technology, Engineering and Math) with Software related studies/courses
• 6+ years of relevant experience in medical device development.
• Experience with risk management and requirements traceability.
• Experience in medical device regulatory standards for SW life cycle.
  
  

• Experience in HW testing and qualification (HALT HASS, IEC 60601 standards).
• Experience in usability (IEC 62366) and GUI development.
• Experience with a host of communication protocols: I2C, RS422, USB, HDMI, TCPIP.
  
  

• Strong documentation
• Must be able to work in a team environment, including inter-departmental teams.
• Strong problem-solving, organizational, analytical and critical thinking skills.
• Substantial understanding of processes and equipment used in assigned work.
• Strict attention to details.
• Ability to manage competing priorities in a fast-paced environment