Imagine how your ideas and expertise can change a patients 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.
Youll bring your passion for problem solving and partner with R&D teams to influence decision-making for a products entire lifecycle. Your work will involve you optimizing product development to impact patients around the world with pioneering technology.
As Principal Design Assurance Engineer/Principal
Design Quality Engineer you will make impact by:
Lead Risk Management activities (including authoring risk management documents).
Collaborate with R&D teams to identify and generate product requirements and ensure regulatory compliace.
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.
Requirements: Bachelors 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.
What else we look for: (Preferred)
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.
This position is open to all candidates.