Biogen is seeking a qualified candidate for the role of device design and process development Engineer II in the Medical Devices & Packaging Department.  The position will lead the design and process 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.

Responsibilities:

• Creating innovative solutions aligned to the drug pipeline.  Make basic decisions that involve direct application of technical knowledge; Performs work in a structured environment under direction from supervisor within own work group/team; Uses established procedures and methodologies.
• Optimize design for usability, design robustness and manufacturability.  Applies technical skills to complete assigned work/experiments within own group/project team.
• Create experimental plan, data and reports.  Analyzes results of basic experiments, information and standard practices using established protocols and methodologies to solve routine problems.
• Assist with project planning including organizing experiments and staff, meetings.  Provides support on projects of varying size; demonstrates awareness of broader project objectives.
• Develop relationships with other groups.  Exchanges straightforward information; asks questions and checks for understanding; organizes and presents data/ information for internal audiences.
• Continuing contribution to CMC teams, prep of regulatory filings and working with external collaborators

• Demonstrated Design for Six Sigma (DFSS) and Design for Manufacturing (DFM) experience
• Demonstrated patient centered design emphasis and Human Factor Engineer experience
• Knowledge of the regulatory and compliance requirements of device/combination products design controls and manufacturing in US/EU/ROW
• Comfortable working in a matrix environment, while embracing and driving change
• Demonstrated problem-solving skills and strong hands-on experience
• Demonstrated ability to facilitate the interface between the pharmaceutical company and the medical device vendor base
• Good communication, collaboration and team building skills

Education

Bachelor’s Degree in Engineering with 2-4 years of experience, or Master’s Degree with 0-2 years of 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 Engineer II in the Medical Devices & Packaging Department.  The position will lead the design and process 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.