About This Role
Biogen is seeking an experienced Medical Device Software Quality Engineering professional to lead software and associated hardware new product design and development of Software as Medical Device (SaMD) and Software in Medical Device (SiMD). This role will serve as the primary subject matter expert for all software related Quality Assurance (QA) activities as well as ensuring that the software development lifecycle satisfies the requirements for all relevant regulations and standards. This position can be remote or hybrid.
What You’ll Do
- Manage a team of software quality device engineers
- Serve as the Quality Lead on the cross-functional device development teams and medical device suppliers and testing partners during the device design/development phases with instructive responsibilities throughout the device lifecycle; relationship building and mentorship of others as part of the role.
- Lead the cross-functional PO&T Quality Asset Sub-Team in the development of and delivery of the product.
- Lead the development, implementation, and continuous improvement of device-related quality processes and procedures and ensure compliance to the relevant standards and regulatory requirements for medical devices products (including ISO 13485, 21 CFR 820, IEC 62304 software classification, and new SaMD/SiMD global regulations and guidance)
- Maintain Biogen’s Quality Management System (QMS) for SaMD/SiMD, including activities required to ensure that the company’s processes and products comply with applicable quality standards and requirements
- Lead post-market quality activities such as change management, product complaint support, and Deviations/CAPAs
- Keep Quality line management and Asset leadership informed of device product development timelines, progress, and challenges.
Who You Are
You are the primary Quality representative for SaMD/SiMD development for use with Biogen therapies with a passion for innovation, compliance, and our patients. You thrive in a fast-paced, agile environment.
- Minimally BS/BA in computer science, computer engineering, or related discipline or equivalent experience
- Minimum of 10 years in a new product design and development of software as medical device role
- Thorough knowledge of FDA 21CFR 820, ISO 13485:2016, ISO 14971:2019, 2017/745, GAMP5, and IEC 62304
- Master’s degree
- Three years of experience in a managerial role
- Excellent problem solving, interpersonal communication and project management skills
- Excellent communication skills, both verbal and written
- Experience in managing and working with distributed/global team members
- Proven track record of completing projects to specifications
- Experience in hardware medical device design and development