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.  

About This Role  

This position will lead the design control, risk management, and human factors engineering support of patient-centric, safe, reliable, and innovative devices while providing subject matter guidance in Human Factors/Risk Management to sub-team members. The position will work with the program lead to drive key activities throughout development phases of device and combination products and facilitate the deliverables to support regulatory filing, product launch, and post-market surveillance. This role can be in either our Cambridge or Research Triangle Park location.

What You will Do  

• Facilitating the design control process with integrated activities in risk management and human factors engineering for combination products. Makes decisions that require choosing between multiple options to resolve complex problems; Works in ambiguous situations within own workgroup/team; works predominantly within established procedures while introducing some new knowledge and methodologies.
• Support human factors engineering activities from formative usability assessments to final summative design validation studies for combination products. Applies technical and functional knowledge to independently conducts research in the assigned area.
• Assist with project planning regarding Human Factors/Risk Management activities. Conducts independent research; generates internal or external documents/reports and presentations related to own work and produces patentable ideas.
• Develop relationships with other groups. Explains difficult or sensitive information; works to build consensus; Regularly leads discussions and makes presentations in cross-functional meetings, effectively presenting information to explain and defend work.
• Participation in regulatory filings and working with external collaborators. Plays a critical role in the write-up of regulatory filings and answering regulatory questions.

Who You Are?  

Are you a strong Human Factors/Risk Management leader with the ability to facilitate the interface between the pharmaceutical company and the medical device vendor base with good communication, collaboration, and team-building skills; with ability to connect with all levels of the organization?

Do you have experience of working with third-party vendors for Human Factor Studies and developing, or reviewing and approving the project design control documents and project Risk Management documents?

If so, then we would be interested in speaking with you!

Required Qualifications: 

• Bachelor’s Degree with a focus in Engineering.
• 8+ years’ experience in design control, human factors and risk management or related area.

Preferred Qualifications:

• Master’s Degree with a focus in Engineering
• Knowledge of the regulatory and compliance requirements of device/combination products design controls and manufacturing in US/EU/ROW.
• Good understanding of new product introduction, design, and development of extruded, molded and/or assembled device products.
• Proven experience in working cross functionally, leveraging their skills to influence and drive results within the matrix organization.