Senior Engineer II, Device Development

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, 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.

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.

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 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.

Preferred Qualifications: 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.

Job Level: Management

Additional Information: The base compensation range for this role is: $117,000.00-$157,000.00 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 bonus and equity incentive opportunities, designed to reward recent achievements and recognize your future potential based on individual, business unit and company performance. In 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 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 Why Biogen? We are a global team with a commitment to excellence, and a pioneering spirit. As a mid-sized biotechnology company, we provide the stability and resources of a well-established business while fostering an environment where individual contributions make a significant impact. Our team encompasses some of the most talented and passionate achievers who have unparalleled opportunities for learning, growth, and expanding their skills. Above all, we work together to deliver life-changing medicines, with every role playing a vital part in our mission. Caring Deeply. Achieving Excellence. Changing Lives. At Biogen, we are committed to building on our culture of inclusion and belonging that reflects the communities where we operate and the patients we serve. We know that diverse backgrounds, cultures, and perspectives make us a stronger and more innovative company, and we are focused on building teams where every employee feels empowered and inspired. Read on to learn more about Biogen. All qualified applicants will receive consideration for employment without regard to sex, gender identity or expression, sexual orientation, marital status, race, color, national origin, ancestry, ethnicity, religion, age, veteran status, disability, genetic information or any other basis protected by federal, state or local law. Biogen is an E-Verify Employer in the United States.

Location: Cambridge, MA

Type: Full time