Principal Engineer, Device Development (Delivery to CNS)

Biogen SANDBOX•Cambridge, MA

11d

About The Position

The position will lead the novel technology area of device development, with a focus on delivery to the central nervous system (CNS) and other route of administration like SC, IM, IV, aligned to the drug pipeline, as well as execute deliverables with internal stakeholders and external partners for Biogen for all of the device and combination products in Biogen’s portfolio. Biogen is seeking a qualified candidate for the role of Creating and Implementing innovative solutions in the Medical Device and Packaging group within Engineering and Technology organization.

Requirements

10+ years’ experience in either medical device design, electromechanical and sensor technology, tooling, assembly or production controls for assembly.
Deep understanding new product introduction, design and development of extruded, molded and/or a

Responsibilities

Report to the Sr Director of Medical Device and Packaging.
Lead/involved with device development team and relevant cross functional groups in creating innovative solutions aligned to the drug pipeline:
Evaluate and identify device landscape for innovative and implementable solutions, with drug delivery to Central Nervous System, CNS as a target area. Example Intrathecal, Direct and Indirect to Brain
Evaluate and Identify device landscape for delivery to IV, SC and IM Route of Administration, when needed
SME for global platform device technology and required interface/interaction with Drug Molecule development, Container Systems and secondary Packaging
Analyze designs for function, assembly, manufacturability, etc. using Engineering techniques.
Liaise with third parties such as specialist manufacturers, design consultants
Responsible for device selection and liaison with cross functional stakeholders in Early and Late stage development and LCM projects
Provide technical leadership and responsibility for device technologies
Ensure essential platform design robustness is based upon agreed Design for Manufacturing, Assembly and Testing principles
Work and manage key interfaces and line functions in manufacturing, quality assurance, manufacturing and regulatory to progress device development deliverables.