Staff Design Assurance Engineer (Remote/Flexible)

Job Title: Staff Design Quality Assurance Engineer -Integrated Solutions 

Department: Design Quality Assurance 

FLSA Status:             Exempt   

Position Overview:  

This position is responsible for leading Design Quality Assurance and Quality Engineering activities throughout the Product Development Lifecycle for new product development. This includes ensuring that the Systems development process is compliant with applicable standards, regulations, and guidance documents for medical devices.  This role will interface with other Insulet departments (e.g. Management, Operations, Engineering, and Regulatory Affairs) as well as vendors and other external parties on issues related to Product Development, and software used for automation of the quality system. The ability to effectively communicate systems design and development regulatory requirements, optimize the development process, and ensure ambiguities and conflicting requirements are resolved are critical to the success of the position.  

Responsibilities:  

• Design Quality Assurance Lead of Design Controlled product areas, ensuring compliance to applicable regulations including ISO 13485, FDA Quality System Regulation 21 CFR Part 820 and General Principles of Software Validation.  

• Lead the systems quality assurance programs, processes, procedures, and controls to ensure compliance with FDA regulations and established standards such as IEC 62304 

• Review requirements, specifications, design documents, validation plans and reports, user acceptance protocols, test plans, test cases, traceability matrices and other documentation as required and provide timely feedback. 

• Lead Design Control initiatives to develop appropriate Design History File documents for FDA Class II and Class III medical devices, including cloud-based mobile apps. 

• 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 systems level development deliverables. 

• Collaborate with Project Management to support and optimize the Design Control and continuous improvement initiatives to optimize our Systems Development Processes.  

• Support development teams on the validation of software tools. 

• Support execution of Risk Management Activities for complex systems in compliance with ISO14971 and software risk requirements in IEC 62304 

• Work with software, hardware, user experience, marketing, manufacturing, and quality assurance on generation, documentation, verification, and validation of requirements.  

• Provide lead support for the creation of necessary documentation to comply with regulatory requirements and industry best practices. 

• Provide expertise in establishing good product requirements, specifications, system design/architecture, verification and validation protocols and planning documentation. 

• Provide guidance on and participate in systems development activities including design 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: 

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 systems development. 

• A minimum of 7+ years of work experience in Systems or software 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, 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 structured phase-gate product development processes. 

• Experience with systems design V&V  

• Familiarity with various software development tools (e.g. configuration management, issue/defect tracking, requirements analysis, etc.). 

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

Preferred Skills and Competencies:  

• Proficient in Microsoft Office Tools (Word, Excel, PowerPoint) 

• Expertise in collaborating and communicating with individuals at multiple levels in an        organization. 

• Ability to prioritize and manage critical projects and 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-energy environment. 

• ASQ, CSQE or other software quality certificates are beneficial, but not required. 

• Experience with SAFe Agile software development methodology beneficial, but not required. 

• Experience with process validations preferred but not required