Sr Staff DQA Engineer (Hybrid)

Job Title: Senior Staff Design Quality Assurance Engineer

Department: Design Quality Assurance

FLSA Status: Exempt

Position Overview:

This position is responsible for leading Quality Assurance activities throughout the Product Development Lifecycle for new product development initiatives as well as design changes to commercialized products. This includes ensuring that the product 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, and launched product support.

Responsibilities:

Support Design Control and Product Development initiatives to develop appropriate Design History File documents for FDA Class II 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 non-product software tools and tools utilized in the development process.

Provide guidance for the generation, review, and approval of design control documentation.

Collaborate with Project Management to support the Design Control process and Continuous Improvement initiatives to optimize our Product Development processes.

Serve as the Design Control expert to product development organization.

Develop and deliver Design Control training for the product development organization.

Review requirements, specifications, product design documents, design verification and 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

Support and provide guidance on product development activities including design and technical reviews, requirements analysis and tracing, defect tracking, and configuration management.

Working knowledge of Software Development Life Cycle (IEC 62304), Design Controls (ISO 13485) and other regulatory requirements and agencies as it relates to Design Quality Assurance activities in product development.

Maintain effective communication with the project team to ensure that user needs, requirements, plans, verification and validation documents, risk assessments, and other documentation is complete.

Education and Experience:

ASQ, CSQE or other 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 product development and product development lifecycles.

Experience with a risk-based approach to validate Commercial off the Shelf (COTS) software and non-product SW Tools.

Experience with complex medical device systems comprised of Hardware, Embedded SW, mobile applications, cloud-based systems,

A minimum of 10 years work experience in Design Quality Assurance or Design 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 product/software development tools (e.g. configuration management, issue/defect tracking, requirements analysis, etc.).

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  

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.