Senior Director, Device Development – Product Delivery Solutions

Biogen

Senior Director of Device Development at Biogen leading drug-device combination product development and enhancing patient experiences. Collaborating across engineering teams and maintaining device technical strategies.

Posted 5/22/2026full-timeCambridge • Massachusetts • 🇺🇸 United StatesSenior💰 $225,000 - $310,000 per yearWebsite

About the role

Key responsibilities & impact

Define and execute the end-to-end strategy for drug-device combination product development aligned to portfolio goals, inclusive of concept, clinical, commercial and lifecycle management of combination product presentation
Influence and translate early molecule needs into device roadmaps and delivery strategies with an emphasis on subcutaneous delivery.
Own technical execution of design control process with hands-on leadership of prototyping, verification and validation activities.
Lead root cause investigations, deviations and CAPAs
Solve complex technical challenges in drug-device integration and delivery performance to ensure robust device performance, reliability and manufacturability.
Ensure integration of drug product and device components to drive system-level architecture and interface definition.
Lead and develop multidisciplinary engineering teams that serve as device subject matter experts and are both external facing to device manufacture and internal facing to combination product development teams to innovate and develop device solutions.
Identify and mitigate technical, regulatory and supply risks through implementation of design and process risk controls, risk management and problem solving.
Manage prototyping and device development laboratories to accelerate design and risk reduction.
Drive robust, data-driven decision-making through model-informed development practices.
Enhance Biogen’s internal and external recognition in combination product development.
Inform regulatory strategies and participate in regulatory meetings as needed.
Develop strategic relationships with key external partners and stakeholders.
Represent Biogen in external industry forums to elevate the organizational voice.
Ensure alignment and integration in planning and milestone delivery across development programs.

Requirements

What you’ll need

Bachelor’s degree in Engineering with at least 15 years of relevant experience.
Equivalent experience may also be considered (MS+12 years of experience or PhD+ 8 years of experience).
Extensive experience in drug device combination product development within the medical device and pharmaceutical industry.
Ability to lead and influence across matrixed organizations.
Deep understanding of root cause investigations, human factors, regulatory requirements, and device design controls.
Proven track record of developing strategic device solutions and managing complex technical projects.
Experience with model-informed development practices and digital twin simulation.
Established external network within the subcutaneous drug delivery device ecosystem.
Strong ability to anticipate business needs and inform device strategies.
Strong communication and team-building skills.

Benefits

Comp & perks

Medical, Dental, Vision, & Life insurances
Fitness & Wellness programs including a fitness reimbursement
Short- and Long-Term Disability insurance
A minimum of 15 days of paid vacation and an additional end-of-year shutdown time off (Dec 26-Dec 31)
Up to 12 company paid holidays + 3 paid days off for Personal Significance
80 hours of sick time per calendar year
Paid Maternity and Parental Leave benefit
401(k) program participation with company matched contributions
Employee stock purchase plan
Tuition reimbursement of up to $10,000 per calendar year
Employee Resource Groups participation

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills & Tools

drug-device combination product developmentdesign control processprototypingverificationvalidationrisk managementmodel-informed development practicesdigital twin simulationroot cause investigationsdevice design controls

Soft Skills

leadershipinfluenceproblem solvingcommunicationteam-buildingstrategic thinkinganticipation of business needscollaborationstakeholder managementmultidisciplinary team development

Certifications

Bachelor’s degree in EngineeringMaster’s degree in EngineeringPhD in Engineering