Senior Staff Engineer, Design QA, Hardware and Embedded SW

4 weeks ago


Acton, Massachusetts, United States Insulet Corporation Full time

At Insulet Corporation, we're committed to empowering our customers to live healthier lives through innovative technology. As a Senior Staff Engineer, Design QA, Hardware and Embedded SW, you'll play a critical role in ensuring the development process for our medical devices is compliant with applicable standards, regulations, and guidance documents.

This includes overseeing Design Assurance and Quality Engineering activities throughout the Development Lifecycle for new product development initiatives involving Hardware and Embedded Software Systems. You'll interface with various Insulet departments, including Research and Development, Lifecycle Engineering, Operations, Engineering, Human Factors, and Regulatory Affairs, as well as external parties on issues related to product development, launched product support, and services.

Key Responsibilities:

  • Lead cross-functional development teams supporting development efforts for Hardware and Embedded Software Systems.
  • Provide oversight and support for the generation and approval of all Design History File deliverables.
  • Ensure compliance to the Software Development Life Cycle (IEC 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 technical expertise to Design Quality Assurance Organization supporting new product development and lifecycle engineering initiatives.

Requirements:

  • BS degree in Electrical Engineering, Mechanical Engineering, Systems Engineering, Physics, or Science degree.
  • A minimum of 8 years work experience in Design Assurance/Quality/Product Design and Development within an FDA, ISO, or other regulated environment.
  • Proven experience delivering successful products to market.
  • Subject Matter Expert for Design Controls (FDA 21 CFR Part 820), and Design and Development /Product Realization (ISO)

Preferred Skills and Competencies:

  • Master's degree preferred.
  • ASQ, CQE or other quality certificates are preferred.
  • Demonstrated ability to collaborate with individuals at multiple levels across the organization.


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