Biogen Senior Engineer II, Device Design and Development Technical Lead in Cambridge, Massachusetts
About This Role * Biogen is seeking a qualified candidate for the role of device design and development Senior II Engineer, Technical lead in the Devices Design and Process Development group. The position will lead the design and development of patient-centric, safe, reliable, and innovative devices. Beginning with continuous research of cutting-edge technology to develop delivery systems integrated with the pipeline. Effectively and efficiently bring optimized products to market through rigorous science and engineering by leveraging external partnerships in collaboration with internal Human Factors, Packaging, Manufacturing Science, Engineering, Quality and Regulatory Affairs etc. *What You’ll Do * * Creating innovative device/combination product/digital health solutions aligned to the drug pipeline. Identify multiple solutions and recommend a course of action to leadership; make complex decisions and troubleshoot in ambiguous situations across the department; creates an environment of experimentation; works across disciplines/functions to test and advance innovative processes and methodologies. * Optimize design for usability, design robustness and manufacturability. Applies technical, functional, and business knowledge to design experiments/ projects that contribute to strategic direction of department/discipline/group. * Create experimental plan, data, and reports. Develops and promotes the use of novel approaches within own area of expertise; routinely investigates/creates innovative processes, hypotheses, and methodologies to solve unique and complex problems. * Assist with project planning including organizing experiments, staff, meetings. Engages in publishing internal and external documents, and presentation of own scientific work, as required; Collaborates with others to expand business opportunities within the function/division. * Develop relationships with other groups. Communicates difficult concepts and negotiates with others to adopt a different point of view; presents supportive arguments for highly complex ideas and projects to internal governance bodies and external stakeholders in a way that persuades them to adopt a different point of view, when appropriate. * Plays critical role in write-up of regulatory filing and answering regulatory questions. Participates in face-to-face meeting with regulatory agencies. * Liaise with third parties such as contract design and manufacturing companies, testing lab etc. * Lead technical team and/or cross-functional project team. *Who You Are * An ambitious and high performing with exceptional interpersonal and communication skills. Having the ability to influence behaviors, manage stakeholders, negotiate, and resolve challenges with tact and diplomacy. Complex problem-solving individual with skills and strong hands-on experience. Experience of leading technical teams and cross-functional project teams. Can define and execute projects using project management techniques with proven results in meeting customer requirements and expectations. *Required Skills * * Bachelor’s Degree in Engineering * 8+ years’ experience _medical device design and process development_ or related area *Preferred Skills * Master’s Degree in Engineering with a focus on Mechanical, Bio-Mechanical with 6+ years’ experience in medical device design and process development or related area. * Ph.D in Engineering with a focus on Mechanical, Bio-Mechanical with 2+ years’ experience in medical device design and process development or related area. * Experience in combination product (such as autoinjector, pre-filled syringe, wearable injector, pen injector, reconstitution device etc.), implants, ophthalmology, and digital health * Experience facilitating the interface between the pharmaceutical company and the medical device vendor base. Ability to communicate and direct supplier activities at the management level. * Proven experience in launching of combination product through the entire development cycle in a CMC environment. * Deep device design and development knowledge of first principles analysis, tolerance analysis, FEA, DOE, Design for Six Sigma (DFSS) and Design for Manufacturing (DFM) etc. * Deep knowledge of the regulatory and compliance requirements of device/combination products design controls and manufacturing in US/EU/ROW. Experience with 510k, PMA, HDE, NDA, BLA, MDD, MDR. * Deep understanding of new product introduction, design, and development of extruded, molded and/or assembled device products as well as testing and modeling methodologies. * Demonstrated good decision-making capability and driving alignment within matrix organization. *Why Biogen? * Our mission to find therapies for neurological and rare diseases is a unique focus within our industry and this shared purpose is what connects us as a team. We work together to overcome obstacles and to follow the science. We are resilient as we strive to make an impact on our patients’ lives and on changing the course of medicine. Together, we pioneer. Together, we thrive.