Sr. Engineer II - Device Human Factors/Risk Management (Combination Products) at Biogen in Research Triangle Park, North Carolina

Posted in Other 15 days ago.

Type: Full Time





Job Description:

Job DescriptionThis 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 located in either our Cambridge or Research Triangle Park location.Responsibilities: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.QualificationsKnowledge 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.Ability to facilitate the interface between the pharmaceutical company and the medical device vendor base.Good communication, collaboration, and team-building skills; ability to connect with all levels of the organization.Some experience of working with third-party vendors for Human Factor Studies.Develop, or review and approval of project design control documents and project Risk Management documents.EducationBachelor's Degree in Engineering required, Master's Degree preferred, plus 8+ years' experience in design control, human factors and risk management or related area.Additional InformationThis exciting career opportunity willwork 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.PDN-91c64223-6624-4f55-9d07-331512ee29f0