SW Quality Assurance Engineer; Hybrid

Overview

Staff SW Quality Assurance Engineer (Hybrid) – Insulet Corporation

This position is responsible for leading Quality Assurance and Quality Engineering activities throughout the Software Development Lifecycle for new product development initiatives and for automated data processing systems used as part of the quality system. This role ensures that the software development process is compliant with applicable standards, regulations and guidance documents for medical devices, including supporting Cyber security development processes and Cyber Bill of Materials.

The role interfaces with internal departments (e.g., Research and Development, IT-Cybersecurity, Sustaining, Engineering, Human Factors, Regulatory Affairs) and external parties on issues related to product development, launched product support, and software used for automation of the quality system. This position is eligible for hybrid working arrangements (requires on-site work from an Insulet office; may work remotely other days).

• Lead Design Control and Software Development initiatives to develop appropriate Design History File documents for FDA Class II and Class III medical devices, mobile applications, cloud-based systems, and cybersecurity.
• Ensure compliance to IEC 62304 and FDA Guidance on Software Contained in a 510(k) Submission.
• Support cybersecurity risk management for both US and ROW requirements.
• Support development teams on the validation of software tools.
• Provide guidance for the generation, review, and approval of design control documentation with primary focus on software development deliverables.
• Collaborate with Project Management to support the Design Control process and Continuous Improvement initiatives to optimize SW Development processes.
• Serve as the Design Control expert to the software development organization.
• Develop and deliver Design Control training for the software development organization.
• Provide expertise in establishing good software requirements, specifications, detailed design, verification and validation protocols and planning documentation.
• Review requirements, specifications, product design documents, validation protocols, test plans, test cases, and other documentation as required and provide timely feedback.
• Support creation of necessary documentation to comply with regulatory requirements and industry best practices.
• Support execution of Risk Management Activities for complex systems in compliance with ISO
  14971 and software risk requirements in IEC 62304.
• Establish and maintain software quality assurance processes, procedures, and controls to ensure compliance with FDA regulations and IEC 62304.
• Provide guidance on, and participate in software development activities including design and code reviews, requirements analysis and tracing, defect tracking and configuration management.
• Maintain working knowledge of Software Development Life Cycle (IEC 62304), Design Controls (ISO 13485) and other regulatory requirements as they relate to Quality Assurance activities in software development; communicate effectively with project software engineers to ensure user needs, requirements, plans, verification and validation documents, risk assessments, and other documentation are complete.

• BS degree in computer science, computer engineering or equivalent field;
  Master’s degree preferred.
• Experience with medical device software development; cloud software in medical devices preferred.
• Experience with a risk-based approach to validate Commercial off the Shelf (COTS) software and SW tools.
• Experience with software mobile applications, cloud-based systems, and cybersecurity.
• Minimum of 8 years of work experience in Software Quality Engineering within an FDA, ISO, or other regulated environment and/or equivalent combination of education and experience.
• Experience in the development and implementation of effective Design Control Systems.
• Working knowledge of Quality System Regulation (FDA 21 CFR Part 820) and ISO 13485 quality system standards.
• Working knowledge of IEC 62304, ISO 14971, IEC 62366, IEC 60601, and FDA guidance on software development, cybersecurity, and 510(k)…