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. This position will contribute to the design and development of patient-centric, safe, reliable, and innovative devices for drug delivery, as well as sustaining engineering of existing products released to market. By applying research of cutting-edge technology and developing multidisciplinary drug delivery systems you will support Biogen’s drug product pipeline.This Senior Engineer will effectively and efficiently bring optimized products to market through rigorous science and engineering, leveraging external partnerships in collaboration with internal teams, including Human Factors, Packaging, Manufacturing, Engineering, Quality, Regulatory Affairs, and other cross-functional stakeholders.This is a hybrid role based at our Headquarters in Cambridge, MA.What You Will Do Design innovative drug delivery devices and combination products aligned to Biogen’s drug product pipeline. These products may range from the selection of pre-filled syringes to the design of implantable drug delivery systems.Troubleshoot technical and design problems in drug delivery systems.Optimize design for usability, design robustness, and manufacturability.Develop experimental plans, analyze data, and prepare comprehensive reports.Assist with project planning, including organizing experiments, staff, meetings, and publishing and presenting ideas externally to impact the technical community.Develop relationships with other groups. Communicate complex technical concepts to internal and external stakeholders.Contribute to the writing of regulatory filings and answer regulatory questions. Participate in face-to-face meetings with regulatory agencies. Liaise with third parties, including contract design and manufacturing companies, testing labs, and other experts.Who You Are You are a driven, high-performing engineer with hands-on experience and good interpersonal and communication skills. With Biogen being a pioneer in this space, you will have the opportunity to participate, learn new technologies, and work on various innovative initiatives. You should have experience working on new product designs and sustaining engineering of released medical device products.Qualifications Required Qualifications: Bachelor’s degree in biomedical, electrical, mechanical engineering, or related engineering degree with a minimum 6 years of experience in product design.Demonstrated experience in drug delivery and combination products, such as autoinjectors, pre-filled syringes, wearable injectors, pen injectors, or drug reconstitution devices.Knowledge of regulatory and compliance requirements for device and combination product design controls and manufacturing in the US, EU, and other regions. Experience with ISO 13485, ISO 14971, 510 (k), PMA, MDD, and MDR.Preferred Qualifications: Advanced degree in biomedical, electrical, or mechanical engineering.Experience developing and launching a drug combination product through the entire product development lifecycle.Knowledge of device design and development, including first-principles analysis, tolerance analysis, Finite Element Analysis (FEA), Design of Experiments (DOE), Design for Six Sigma (DFSS), and Design for Manufacturing (DFM).Experience with Life Cycle Management and CAPA software (Oracle PLM, Trackwise)Experience with Technical Product Complaints and Root Cause AnalysisUnderstanding of new product introduction, design, and development of extruded, molded, and/or assembled device products, as well as testing and modeling methodologies.Additional Information The base salary range for this position is $103,000-$165,000. Base salary offered is determined through an analytical approach utilizing a combination of factors, including, but not limited to, relevant skills & experience, job location, and internal equity.Regular employees are eligible to receive both short-term and long-term incentives, including cash bonuses and equity incentive opportunities, designed to reward recent achievements and recognize their future potential based on individual, business unit, and company performance.BenefitsIn addition to compensation, Biogen offers a full and highly competitive range of benefits designed to support our employees and their families' physical, financial, emotional, and social well-being, including, but not limited to:Medical, Dental, Vision, & Life insuranceFitness & Wellness programs, including a fitness reimbursementOn-site childcare facility in CambridgeShort- and Long-Term Disability insuranceA minimum of 15 days of paid vacation and an additional end-of-year shutdown time off (Dec 26 to Dec 31)Up to 12 company paid holidays + 3 paid days off for Personal Significance80 hours of sick time per calendar yearPaid Maternity and Parental Leave benefit401(k) program participation with company-matched contributionsEmployee stock purchase planTuition reimbursement of up to $10,000 per calendar yearEmployee Resource Groups participation