Position Overview: 
The Senior SW Design Quality Assurance Engineer is responsible for ensuring new products conform to the Insulet Quality System, Quality System Regulation, ISO 13485 and ISO14971. He/she is responsible for maintaining a strong collaborative partnership with cross-functional team members. He/she will serve as a Quality representative on Cloud-based product development to improve awareness, visibility, and communication on all quality initiatives to support departmental, functional and corporate quality goals and priorities. He/she can effectively communicate with all levels of the organization. This role will interface with other Insulet departments (e.g., Research and Development, Product Security, DevOps, Engineering, IT, and Regulatory Affairs) as well as other external parties.

 

 

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.
• Ensures compliance to 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.
• 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 our SW Development processes.
• Serve as the Design Control expert to 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 ISO14971 and software risk requirements in IEC 62304
• Establish and maintain software quality assurance processes, procedures, and controls to ensure compliance with FDA regulations and established standards such as 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
• Applies a good working knowledge of Software Development Life Cycle (IEC 62304), Design Controls (ISO 13485) and other regulatory requirements and agencies as it relates to Quality Assurance activities in software development. Maintain effective communication with the project software engineers to make sure that user needs, requirements, plans, verification and validation documents, risk assessments, and other documentation is complete.

Education and Experience:

• ASQ, CSQE or other software quality certificates are beneficial.
• BS degree, in an engineering/scientific/computer systems/ or quality management curriculum or equivalent experience.  Master’s degree preferred.
• A minimum of 2-5 years work experience in Quality Assurance within an FDA, ISO or other regulated environment and/or equivalent combination of education and experience.
• Experience with medical device software development.
• 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.
• 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 510(k).
• Familiarity with various software development tools (e.g. configuration management, issue/defect tracking, requirements analysis, etc.).
• Experience with software development lifecycles with emphasis on the software quality engineering aspects.

Skills/Competencies:

• Effective verbal and written communication skills.
• Experience collaborating and communicating 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.

Hybrid:
NOTE: This position is eligible for hybrid working arrangements (requires on-site work from an Insulet office 1x/week). #LI-Hybrid

Additional Information:

Compensation & Benefits: For U.S.-based positions only, the annual base salary range for this role is $93,675.00 - $140,512.50 This position may also be eligible for incentive compensation. We offer a comprehensive benefits package, including: • Medical, dental, and vision insurance • 401(k) with company match • Paid time off (PTO) • And additional employee wellness programs Application Details: This job posting will remain open until the position is filled. To apply, please visit the Insulet Careers site and submit your application online. Actual pay depends on skills, experience, and education.