Biogen Senior III Digital Device Integration Engineer, Technical Lead in Cambridge, Massachusetts
About This Role * Biogen is seeking a qualified candidate for the role of digital device integration Senior III engineer, Technical Lead in the Devices Design and Process Development group. The position will lead the novel technology area of digital experience and adherence within devices and packaging, with patient centric focus, aligned to the drug pipeline, as well as execute deliverables with internal stakeholders and external partners for Biogen, for the device and packaging products in Biogen’s portfolio. This role bridges the enterprise operation of end-to-end discovery through regulated clinical trial to commercial application in the neuroscience portfolio at Biogen. The successful candidate will have industry experience and evidence of innovation applying novel technologies in the measurement outputs and patient centric adherence and compliance solutions. *What You’ll Do * * Lead efforts in device and packaging digital experience and adherence solutions * Create and evaluate mechanical/electromechanical/software concepts/prototypes with user unmet needs and relevant technology * Optimize design concepts to improve performance for usability and design robustness * Test systems on bench top models, during design verification and human subjects testing. Analyze designs for function, assembly, manufacturability, etc. using both CAE and Engineering techniques related to Design for Six Sigma * Liaise with third parties such as specialist design/development firm or device/packaging manufacturers * Evaluate external device and packaging landscape for innovative and implementable solutions for disease monitoring, adherence, and compliance * Create and develop Intellectual Property in design and utility device and packaging space * Communicate effectively, both verbally and in writing, internally across departments and with external suppliers * Ensure all designs function as required and comply with the Company’s quality assurance requirements as well as applicable regulatory requirements * Interact with Biogen Digital Health Unit *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 * 10+ years’ experience in medical device design, electromechanical and sensor technology, wearables *Preferred Skills * Master’s Degree in Engineering with a focus on Mechanical or Electrical Engineering with 8+ years’ experience in medical device design and process development or related area. * Ph.D. in Engineering with a focus on Mechanical or Electrical Engineering with 5+ years’ experience in medical device design and process development or related area. * Deep understanding of design and development of device products with digital context. * Deep knowledge of the regulatory and compliance requirements of combination product and digital device solution in US, EU and other regions * Experience with SaMD, SiMD, wireless connectivity, cybersecurity * Demonstrated ability to facilitate the interface between the pharmaceutical company and the medical device, packaging vendor base * Experience developing multiple device and packaging products from research through registration and launch. * Strong communication, collaboration and team building skills; ability to connect with all levels of the organization * Comfortable working in a matrix environment, while embracing and driving change 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.