Senior Staff Engineer, Design QA, Hardware and Embedded SW (Remote/Flexible)

Insulet Corporation-posted 9 months ago
$104,325 - $156,487/Yr
Senior
Remote • Acton, MA
Miscellaneous Manufacturing
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The Senior Staff, DQA Engineer will be a Technical Lead for Design Assurance and Quality Engineering activities throughout the Development Lifecycle for new product development initiatives involving Hardware and Embedded Software Systems for Insulet Corporation. This includes ensuring that the development process is compliant with applicable standards, regulations and guidance documents for medical devices containing Embedded Software. This role will interface with other Insulet departments (e.g. Research and Development, Lifecycle Engineering, Operations, Engineering, Human Factors, and Regulatory Affairs) as well as other external parties on issues related to product development, launched product support, and services to support our medical devices, partner integrations, and data analytics.

  • 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.
  • Provide technical expertise to Design Quality Assurance Organization supporting new product development and lifecycle engineering initiatives.
  • Support quality related process/product improvement initiatives throughout the Development Lifecycle and DQA activities within the organization to align with industry best practices.
  • 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 and/or equivalent combination of education and experience.
  • 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 13485).
  • Proficient with Medical Device regulations (IEC 62304, ISO 14971, IEC 62366, IEC 60601, and FDA guidance documents on software development, and cybersecurity).
  • Excellent project team skills; experience and capability working collaboratively under a Quality Management System (QMS), as part of a cross-functional team that includes development, verification/validation, manufacturing, marketing, clinical, regulatory and quality experts.
  • Master's degree preferred.
  • ASQ, CQE or other quality certificates are preferred.
  • Demonstrated ability to collaborate with individuals at multiple levels across the organization.
  • Ability to prioritize and manage critical project timelines in a fast-paced environment.
  • Must be able to handle multiple responsibilities concurrently.
  • Strong analytical and problem-solving skills.
  • Able to work effectively in a high-stress, high-energy environment.
  • Ability to manage people and projects in a fast-moving environment.
  • 100% remote working arrangements (may work from home/virtually 100%; may also work hybrid on-site/virtual as desired).
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