Senior Engineer II, Device Development

Biogen•Cambridge, MA

10d•$117,000 - $157,000•Hybrid

About The Position

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.

Requirements

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 applicable US and EU regulatory expectations.
Experience supporting new product introduction, including design, engineering analysis such as first-principles modeling and FEA, prototyping, development, and testing of extruded, molded, and/or assembled device products, as well as relevant testing and modeling methodologies.

Nice To Haves

Advanced degree in biomedical, electrical, mechanical, or related engineering discipline.
Experience with a requirements, risk management, tracebility software tool (e.g. JAMA DOORS, Polarion, CodeBeamer).
Demonstrated enthusiasm for and fluency in artificial intelligence, with the ability to creatively integrate AI-enabled tools into day-to-day work to streamline workflows, improve productivity and quality, accelerate problem-solving, and identify new ways of working.
Experience developing and launching a drug-device combination product, such as a prefilled syringe, autoinjector, wearable injector, pen injector, infusion system, or related delivery system, from concept through commercialization.
Experience with research and development of electromechanical medical devices, handheld delivery systems, or connected drug delivery technologies.
Knowledge of medical device mechanical engineering tools and frameworks, including Design of Experiments, Design for Six Sigma, and Design for Manufacturing, as well as regulatory and compliance requirements for device and combination product design controls and manufacturing in the US, EU, and other regions.

Responsibilities

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.

Benefits

Medical, Dental, Vision, & Life insurances
Fitness & Wellness programs including a fitness reimbursement
Short- and Long-Term Disability insurance
A minimum of 15 days of 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