Principal Engineer, Device Design and Development
- Cambridge, MA
- 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
- Ambitious and high performing with exceptional interpersonal and communication skills
- With the ability to influence behaviors, manage stakeholders, negotiate and resolve challenges with tact and diplomacy
- Experience in combination product (such as autoinjector, pre-filled syringe, wearable injector, pen injector, reconstitution device etc.), implants, ophthalmology and digital health is preferred
- Proven experience in launching of combination product through the entire development cycle in a CMC environment is highly desired
- 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 is preferred
- 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
- Demonstrated ability to facilitate the interface between the pharmaceutical company and the medical device vendor base. Ability to communicate and direct supplier activities at the management level
- Complex problem-solving skill and strong hands-on experience
- Experience of lead technical team and cross-functional project team. Ability to define and execute a project using project management techniques
- Proven results in meeting customer requirements and expectations
- Bachelor’s Degree in Engineering required, Master’s Degree preferred
- 14+ years’ experience in medical device design and process development or related area
Biogen is seeking a qualified candidate for the role of device design and process development Senior III/Principal Engineer in the Medical Devices Department. 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.
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