Insulet started in 2000 with an idea and a mission to enable our customers to enjoy simplicity, freedom and healthier lives through the use of our Omnipod® product platform. In the last two decades we have improved the lives of hundreds of thousands of patients by using innovative technology that is wearable, waterproof, and lifestyle accommodating.

Job Title:                        Staff SW Design Quality Assurance Engineer

Department:                 Design Quality Assurance

Location:                        Acton, MA

Manager/Supervisor:   Director Design Assurance

FLSA Status:                   Exempt

SOP Group:                    Quality Assurance

Position Overview:
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 includes ensuring that the software development process is compliant with applicable standards, regulations and guidance documents for medical devices including supporting the Cyber security development processes and Cyber Bill of Materials.  This role will interface with other Insulet departments (e.g. Research and Development, IT-Cybersecurity, Sustaining, Engineering, Human Factors, and Regulatory Affairs) as well as other external parties on issues related to product development, launched product support, and software used for automation of the quality system.

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 the 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.
• 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.

• A minimum of 6 years 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 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.
• Ability to influence people and projects in a fast-moving environment.

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

Additional Information:

The US base salary range for this full-time position is $109,560.00 - $164,670.00. Our salary ranges are determined by role, level, and location. The range displayed on each job posting reflects the minimum and maximum target for new hire salaries for the position in the primary work location in the US. Within the range, individual pay is determined by work location and additional factors, including job-related skills, experience, and relevant education or training. Your Talent Acquisition Specialist can share more about the specific salary range for your preferred location during the hiring process. Please note that the compensation details listed in US role postings reflect the base salary only, and do not include bonus, equity, or benefits.