Senior Engineer II, Device Development

About This Role Biogen is seeking a qualified candidate for the role of Senior Engineer II in the Device Development group. The Senior Engineer II, Device Development will contribute to the design, development, and lifecycle management of patient-centric, safe, reliable, and innovative drug delivery devices and combination products. This role will support both new product development and sustaining engineering for marketed products by applying rigorous science and engineering, evaluating emerging technologies, and partnering with internal and external stakeholders to advance optimized delivery systems for Biogen’s pipeline. This position requires strong collaboration across Device Development, Human Factors, Packaging, Manufacturing, Quality, Regulatory Affairs, Clinical, Commercial, and external partner teams to ensure device strategy, requirements, risk management, and execution plans remain aligned with program needs. This is a hybrid role based at our Headquarters in Cambridge, MA.

Develop and maintain combination product Design History File content, including design input requirements, design outputs, design reviews, verification and validation strategies, protocols, reports, and traceability documentation. Support risk management by translating knowledge of user interactions, clinical use scenarios, device design, and product performance into risk assessments; establishing traceability to design input requirements; and authoring risk-based verification and validation plans. Lead technical issues to resolution by documenting investigations, performing root cause analysis, evaluating vendor complaints, assessing design and process changes, and communicating conclusions and recommendations to cross-functional stakeholders. Support design changes and lifecycle management activities, including impact assessments, technical investigations, risk analyses, change control documentation, and reverification or revalidation planning. Support Device Master Record content and related technical documentation for combination products, including assembly, labeling, packaging, test methods, specifications, and supplier-controlled device constituent part documentation. Control device constituent part development by establishing design outputs, documenting control strategy, assessing observations and deviations, evaluating root cause, and leading technical issues with suppliers and internal partners through resolution. Engage with external partners onsite and virtually, including device constituent part manufacturers, contract development and manufacturing organizations, contract laboratories, technology providers, trade show contacts, and other relevant industry experts. Support innovation projects by conducting technology and drug delivery system landscaping, evaluating feasibility, developing concepts or prototypes where applicable, and translating learnings into recommendations for pipeline programs. Oversee verification activities at contract laboratories by developing experimental plans, analyzing test data, preparing technical reports, and troubleshooting technical and design problems in drug delivery systems. Contribute to project planning by aligning with cross-functional teams on phase-appropriate milestones, identifying critical path activities, communicating and reducing project risks and uncertainties, and leading workstreams to on-time delivery. Contribute to regulatory filings and responses to regulatory questions by preparing device and combination product content, supporting technical justifications, and liaising with third parties, including contract design and manufacturing companies, testing laboratories, and subject matter experts.

You are a driven, high-performing engineer with hands-on device or combination product development experience, strong technical judgment, and effective interpersonal and communication skills. You are comfortable working across functions, partnering with