The Software Compliance Engineer is responsible for navigating teams through the product software quality system. The Software Compliance Engineer provides the software project management and other appropriate management with insight into process implementation and advises the project team on how to implement software processes and standards to best meet the needs of the project.
Working with software project teams to achieve regulatory and organizational compliance to ensure successful regulatory submissions and 3rd party audits.
Lead software project teams to achieve the most efficient, compliant process for product software development to minimize project cost and schedule.
Provide regular process improvement feedback to continually refine the software development process to maximize effectiveness and efficiency.
Software Development Teams
Member of software development team representing Quality.
Perform document reviews and approvals.
Member of software change control board.
Cascade project and functional Quality messages to software development teams.
New Product Development Element Teams
Serve on project Quality element team.
Keep project Quality team informed of software development team activities.
Escalate software project issues to project Quality team.
Functional and Project Management
Escalate software project issues to project Quality and functional Quality management.
The incumbent will:
Serve as Diabetes Care Element Team Representative as requested in support of medical device and mobile/cloud application software-focused stage gated (New Product Development) projects.
Serve as independent stage gate software reviewer for New Product Development and design change projects to ensure that internal procedures, control elements, and stage gate criteria have been fully met.
Take a leadership role on assigned software teams supporting the development of the Software Project Plan. Provide expertise to the software development team regarding software process implementation on the project. Answer questions about software processes and process compliance issues throughout the project lifecycle.
Interface with supplier and customer Quality personnel on software development projects to coordinate software regulatory and development processes and deliverables.
Participate on Software Peer Review committees, Software Milestone Review committees, and NPD Technical Review boards as requested. Provide guidance and expertise on the Software Peer Review process and serve as peer review moderator as requested.
Serve as software Subject Matter Expert support on evaluations and audits of suppliers of software. Prepare supplier software evaluation reports, gap analyses, and risk management plans to ensure that key software suppliers plan and deliver appropriate software and documentation.
Systems thinker who supports process improvement efforts to improve the organizational software quality system to ensure regulatory compliance, audit readiness and to assure state-of-the-art software development methods.
The successful candidate is required to possess the following:
Bachelor's degree in Computer Science, Software Engineering, Computer Engineering, or related field.
Minimum 5 years of experience in a software development environment, with technical software engineering experience (design, coding, testing) preferred.
Experience in process improvement and advanced knowledge of your current organization’s established software processes.
Must be able to work effectively with a diverse group of people, including senior management, project managers and software practitioners, and global Sales and Marketing personnel.
Understanding and experience in medical device software development including, but not limited to, software requirements for FDA PMA and 510k submissions, software requirements for EU IVD Technical Files, and software requirements for China SFDA submissions.
Excellent communication and writing skills, strong negotiation skills, and skills associated with being an effective change agent.
Experience developing systems that consist of medical devices which wirelessly communicate with mobile (iOS, Android) or cloud-based applications.P