Senior Quality Assurance Lead for Hardware and Embedded Software Systems

17 hours ago


San Diego, California, United States Insulet Full time

As a seasoned expert in Design Assurance and Quality Engineering, you will play a pivotal role in ensuring the development process is compliant with applicable standards, regulations, and guidance documents for medical devices containing Embedded Software.

Responsibilities:
  • You will be a key member of cross-functional development teams supporting development efforts for Hardware and Embedded Software Systems.
  • Basic understanding of analog, digital, and mixed signal circuits including custom integrated circuits and simulation (Monte-Carlo, etc).
  • Subject Matter Expert in Design Control to support the development organization. Provide oversight and support for the generation and approval of all Design History File deliverables.
  • Subject Matter Expert for Risk Management Activities for complex systems in compliance with ISO14971.
  • Subject Matter Expert ensuring compliance to the Software Development Life Cycle (IEC 62304) and FDA Guidance on Software Contained in a 510(k) Submission.
  • Support efforts for cybersecurity risk management for both US and Rest of World (ROW) requirements.
  • Provide guidance to the development organization on the generation and review of requirements & specifications, design documents, design verification plans, protocols, and reports, traceability matrices and other documentation as required.
  • Support quality related process/product improvement initiatives throughout the Development Lifecycle and DQA activities within the organization to align with industry best practices.

To excel in this role, you should have a BS degree in Electrical Engineering, Mechanical Engineering, Systems Engineering, Physics, or Science degree, along with a minimum of 8 years of work experience in Design Assurance/Quality/Product Design and Development within an FDA, ISO, or other regulated environment.

The estimated salary range for this position is $99,600.00 - $149,700.00, reflecting the base salary only. This figure may vary based on location and individual factors such as job-related skills, experience, and relevant education or training.



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