Sr. Engineer II - Device Human Factors/Risk Management
Posted on: 29 Jan 2022
Research Triangle Park, NC
Job Description
Job Description
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!
Qualifications
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.
Biogen
Cambridge, MA
Biogen Inc. discovers, develops, manufactures, and delivers therapies for treating neurological and neurodegenerative diseases worldwide. The company offers TECFIDERA, AVONEX, PLEGRIDY, TYSABRI, and FAMPYRA for the treatment of multiple sclerosis (MS); SPINRAZA for the treatment of spinal muscular atrophy; and FUMADERM for the treatment of plaque psoriasis. It also provides BENEPALI, an etanercept biosimilar referencing ENBREL; FLIXABI, an infliximab biosimilar referencing REMICADE; and IMRALDI, an adalimumab biosimilar referencing HUMIRA. In addition, the company offers RITUXAN for the treatment of non-Hodgkin's lymphoma, chronic lymphocytic leukemia (CLL), rheumatoid arthritis, two forms of ANCA-associated vasculitis, and pemphigus vulgaris; RITUXAN HYCELA for non-Hodgkin's lymphoma and CLL; GAZYVA to treat CLL and follicular lymphoma; and OCREVUS for the treatment of primary progressive MS and relapsing MS, and other anti-CD20 therapies.
Further, it is involved in developing BIIB098, Opicinumab, and BIIB061 for MS and neuroimmunology; Aducanumab, Elenbecestat, BAN2401, BIIB092, BIIB076, and BIIB080 to treat Alzheimer's disease and dementia; BIIB092 and BIIB054 for treating Parkinson's disease and movement disorders; BIIB067, BIIB078, and BIIB110 to treat neuromuscular disorders; BIIB093, TMS-007, and Natalizumab to treat acute neurology; BIIB104 for treating neurocognitive disorders; BIIB074 and BIIB095 for pain; and Dapirolzumab pegol, BG00011, and BIIB059 for treating other diseases, which are under various stages of development.
The company offers products through its sales force and marketing groups. Biogen Inc. has collaboration agreements with Genentech, Inc., Eisai Co., Ltd., Alkermes Pharma Ireland Limited, Bristol-Myers Squibb Company, Acorda Therapeutics, Inc., AbbVie Inc., C4 Therapeutics, University of Pennsylvania, Applied Genetic Technologies Corporation, and others. The company was founded in 1978 and is headquartered in Cambridge, Massachusetts.
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IndustryBiotechnology
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No. of Employees7,800
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Website
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Jobs Posted445
