Senior Engineer II, Device Development

Biogen; Cambridge (MA); Presencial; USD 120.000 - 160.000; Jornada completa

Descripción de la vacante

Biogen in Cambridge, MA seeks a Senior Engineer II in the Device Development group to advance design, development, and lifecycle management of patient-centric drug delivery devices and combination products.

The role focuses on new product development and sustaining engineering, collaborating across multiple internal teams and external partners to align device strategy with program needs.

Formación

• Bachelor's degree in biomedical, electrical, or mechanical engineering with 6+ years in device/combination product development.
• 3+ years experience with drug delivery and combination products (autoinjectors, pre-filled syringes, wearable injectors).
• Experience with medical device standards and regulations (ISO 13485, MDR/IVDR) would be advantageous.

Responsabilidades

• Develop and manage design history file content for combination products.
• Translate user interactions and clinical use into risk assessments and verification plans.
• Lead technical issue resolution across cross-functional teams.

Conocimientos

Device development

Combination product development

Drug delivery systems

Educación

Bachelor's degree in biomedical, electrical, or mechanical engineering

Herramientas

ISO 13485

Regulatory standards (FDA ISO)

Descripción del empleo

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.

What You Will Do

• 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, analysing 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.

Who You Are

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 external organizations, and applying structured problem‑solving to advance programs through development and lifecycle management.

You have experience developing medical devices and/or combination products for new product introduction, from concept through commercialization, and you understand the technical, quality, regulatory, and operational considerations needed to bring products to patients.

Qualifications

• Minimum Required Qualifications: Bachelor's degree in biomedical, electrical, mechanical, or related engineering discipline with at least 6 years of experience in device and/or combination product development, including 3+ years of experience with drug delivery and combination products such as autoinjectors, pre‑filled syringes, wearable injectors, pen injectors, or drug reconstitution devices.
• Experience working within medical device and combination product standards and regulations, including ISO 13485, ISO 14971, 21 CFR Part 4, 510(k), PMA, MDD, MDR, and other appli