Insulet Corporation

Sr. Software Quality Engineer

US-CA-San Diego | US-CA-San Diego
2 weeks ago
Category
Quality Assurance / Quality Engineering

Position Summary

This position is responsible for leading Quality Assurance and Quality Engineering activities throughout the Software Development Lifecycle for new product development initiatives. This includes ensuring that the software development process is compliant with applicable standards, regulations and guidance documents for medical devices. This role will interface with other Insulet departments (e.g. Sr. Management, Operations, and Information Technology, Engineering, New Business Development and Regulatory Affairs) as well as other external parties on issues related to product development and launched product support. The ability to effectively communicate software and design and development regulations, optimize the development process, and ensure ambiguities and conflicting requirements are resolved are critical to the success of the position.

Responsibilities

  • 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.
  • Lead Risk Management Activities in accordance with ISO 14971 and software risk requirements in IEC 62304.
  • Ensures compliance to IEC 62304, and FDA Guidance on Software Contained in a 510(k) Submission.
  • Establish and maintain software quality assurance programs, processes, procedures and controls to ensure compliance with FDA regulations and established standards such as IEC 62304
  • Lead effort for cybersecurity risk management for both US and ROW requirements.
  • Lead creation of necessary SW documentation to comply with regulatory requirements and industry best practices.
  • Provide guidance on, and participate in software development activities including design and code reviews, requirements analysis and tracing, defect tracking and configuration management
  • Collaborate with Project Management to support and optimize the Design Control process.
  • Serve as the Design Control expert to software development organization.
  • Develop and deliver Design Control training for the software development organization.
  • Support development teams on the validation of software tools.
  • Work with software, hardware, user experience, marketing, manufacturing, and quality assurance on identifying, writing, testing, and meeting requirements.
  • Review requirements, specifications, product design documents, validation protocols, test plans, test cases, and other documentation as required and provide timely feedback.
  • Performs other duties as assigned.

 

 

Education and Experience

  • CSQE Certification preferred.
  • BS degree, in an engineering/scientific/computer systems/ or quality management curriculum or equivalent experience. Master’s degree preferred.
  • Experience with medical device software development
  • Experience with software mobile applications, cloud based systems, and cybersecurity.
  • A minimum of 10 years work experience in Software Quality Assurance 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 the 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 documents on software development, cybersecurity, and submission requirements for PMA and 510(k)
  • Demonstrated experience organizing and maintaining large documentation sets.
  • Ability to follow up with task owners to close out open items.
  • Experience with structured phase-gate product development processes.

 

Skills/Competencies:

  • Effective verbal and written communication skills.
  • Ability to manage people and projects in a fast moving environment.
  • Experience collaborating and communicate with individuals at multiple levels in an       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.

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