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.

Position Overview:

This position is for leading Design Assurance and Quality Engineering activities throughout the Software Development Lifecycle for new product SW development initiatives and the development of Mobile Applications and Cloud Services for Insulet Corporation. This includes ensuring that the software development process is compliant with applicable standards, regulations and guidance documents for medical devices containing SW and Software as a Medical Device. 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, launched product support, and services to support our medical devices, mobile applications, partner integrations and data analytics. The ability to effectively communicate software and design and development regulations, optimize the development process in an Agile framework, and ensure ambiguities and conflicting requirements are resolved are critical to the success of the position.

Responsibilities:

• Review Design Control and Software Development deliverables including deployment and change control for FDA Class I, II and Class III medical devices, mobile applications, cloud-based systems, and cybersecurity.
• Provide oversight and support for the generation and approval of all Software development artifacts required per design control requirements related to the deployment and release of new cloud and mobile apps products, ensuring deliverables meet Design History File requirements. Oversee the creation of necessary documentation to comply with regulatory requirements and industry best practices
• Ensures compliance to IEC 62304, and FDA Guidance on Software Contained in a 510(k) Submission.
• Collaborate with DQA, R&D, and Project Management to support and optimize the Design Control and SW Development Processes within an Agile Framework.
• Support the training efforts for the software development organization.
• Provide guidance to the development organization on the validation of software tools.
• Understand Risk Management Activities in compliance with ISO14971 and software risk requirements per IEC 62304
• Continuously contributes to improvements of Insulet’s Quality Management System, processes, procedures, and controls to ensure compliance with FDA regulations and established standards such as IEC 62304 and industry best practices.
• Ensure compliance to the Software Development Life Cycle (IEC 62304), Design and Development (ISO 13485), Medical Device Risk Management (ISO14971) and other regulatory requirements and agencies as it relates to Quality Assurance activities in software development.

Education and Experience:

Minimum Requirements:

• BS degree, in an engineering/scientific/computer systems/ or quality management curriculum and 7+ years or equivalent combination of education/experience.
• Experience with medical device software development.

• A minimum of 7+ 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, including cybersecurity requirements.
• 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.
• Experience with software development lifecycles, including SAFe Agile software development methodology as well as structured phase-gate product development processes.
• Familiarity with various software development tools (e.g. configuration management, issue/defect tracking, requirements analysis, etc.).

Preferred Skills and Competencies:  

• ASQ, CSQE or other software quality certificates are preferred.
• Effective verbal and written communication skills.
• 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.

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 $99,600.00 - $149,700.00. 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.