Senior Software DQA Engineer

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.

We are looking for highly motivated, performance driven individuals to be a part of our expanding team. We do this by hiring amazing people guided by shared values who exceed customer expectations. Our continued success depends on it!

The Senior Software DQA Engineer 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 and GxP computerized systems.

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 software used for automation of the quality system. 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.

• 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.

• 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 and optimize the Design Control and SW Development Processes.

• 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 generation, documentation, verification and validation of requirements.

• Assist with the execution of validation testing for computerized systems that are used as part of production processes or in the quality system.

• Lead creation of necessary documentation to comply with regulatory requirements and industry best practices.

• Lead Risk Management Activities for complex systems in compliance with ISO14971 and software risk requirements in IEC 62304.

• Establish and maintain software quality assurance programs, processes, procedures and controls to ensure compliance with FDA regulations and established standards such as IEC 62304

• Provide expertise in establishing good software requirements, specifications, detailed design, verification and validation protocols and planning documentation

• Provide guidance on, and participate in software development activities including design and code reviews, requirements analysis and tracing, defect tracking and configuration management

• Review requirements, specifications, product design documents, validation protocols, test plans, test cases, and other documentation as required and provide timely feedback.

• 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.

Minimum Requirements: 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 computerized systems, Commercial off the Shelf (COTS) software and SW Tools.

• Experience with software mobile applications, cloud-based systems, and cybersecurity.

• A minimum of 5 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 PMA and 510(k).

• Demonstrated experience organizing and maintaining large documentation sets.

• Experience with structured phase-gate product development processes. • Familiarity with GAMP 5 guidance.

• Experience with software design V&V, computerized systems validations, and process validations.

• 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 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.

• Ability to manage people and projects in a fast-moving environment.

NOTE: This position is eligible for 100% remote working arrangements (may work from home/virtually 100%; may also work hybrid on-site/virtual as desired). #LI-Remote

Additional Information:

The US base salary range for this full-time position is $90,530.00 - $136,070.00. 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.

At Insulet Corporation all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran.

(Know Your Rights)