Sr. Biomedical Engineer - Cell and Gene Therapy

Position Summary
Working within the Fractyl’s Cell and Gene Therapy Research Team, the Sr. Biomedical Engineer is responsible for contributing to Fractyl’s cell and gene therapy initiatives centered on treating unmet needs due to metabolic disease.  S/he will work on early stage R&D, and be integral to discovering and developing the next generation of cell and gene therapies whose localized delivery to the intestine is enabled through device and process innovation. The position requires enthusiasm, passion, attention to detail, team-orientation and an entrepreneurial spirit, and a desire to overcome obstacles to drive forward the program.  
Primary Responsibilities
·       Provide biomedical engineering contribution to Fractyl cell and gene therapy program. Perform process optimization and technology development to enable cell and gene therapy and regenerative medicine of the intestine. This includes definition of tasks, experiment planning and execution, data analysis, documentation, SOP preparation, reporting, and recommendation development.
·       Conceptualize, design, and build early-stage prototype devices for the targeted delivery of virus to the intestine.
·       Test, evaluate and improve upon existing equipment and devices.  Develop written test protocols and test reports to evaluate design performance.  
·       Participate in the development of intellectual property and crafting of patents related to current and future company products.
·       Work with scientists and external vendors to research new viral-based medical procedures and products in pre-clinical small and large animal models.
·       Design, perform, and report results of bench and in vivo experimental protocols for novel gene therapy products.
·       Experience interfacing with Quality and Regulatory teams
·       Understanding of the product development process, design controls, device requirements generation, and risk management
·       Participate in planning of project timelines and budgets, including technical and project risk analysis.  Help develop realistic project plans, stage-gate deliverables, conduct design reviews, and anticipate project roadblocks, delays and risks. Utilize appropriate escalation and communication techniques to resolve issues.
·       Identify and bring to Fractyl new technologies to support the goals of the cell and gene therapy objectives.
·       Drive forward program goals to meet team objectives, working closely with CROs and internal teams.
·       Manage CRO activities, including study design, study execution, data analysis, and documentation.
·       Bring a “can do” spirit to work and deliver on other responsibilities as assigned
Education or Certification Requirements
·       Bachelors, in Biomedical Engineering, Bioengineering, Mechanical Engineering or relevant field required; advanced degrees a plus
Professional Work Experience
·       5+ years of related experience in an industry environment; Experience in Med Device required, with experience in the biotech and/or pharmaceutical industries valued but not required
·       Extensive hands-on experience in design/prototyping of small components for implantable drug/device combination products or catheters, and other gastrointestinal medical devices highly preferred
·       Experience in biotech, pharmaceutical and/or medical device industries preferred
·       Prior vocational experience in related fields a plus (i.e. Co-Ops, Internships, Fellowships, etc.)
Qualifications and Skills
·       Experience with early-stage device prototyping and knowledge of rapid prototyping techniques 
·       Experience designing and executing bench and/or in vivo experimental protocols
·       Experience in problem solving related to drug delivery to specifics regions of a complex, multicellular tissue
·       Strong understanding of engineering design principals and methodologies
·       Experience in catheter-based technology preferred
·       Understanding of biological systems to advance device-mediated gene therapy of the intestine
·       Experience or willingness to work with small and large animal models as needed to drive forward program goals
·       Familiarity with a variety of molecular and cellular biology techniques
·       Track record of challenging oneself to enhance scientific abilities
Other Essentials and Key Success Factors
·       Successful track record of working in high-growth and dynamic organizations
·       Bring a “can do” spirit to work and deliver on other responsibilities as assigned 
·       Demonstrated record of intellectual curiosity, innovation and creative problem solving with an entrepreneurial spirit
·       Ability to lead fast-paced projects with a keen sense of urgency to get the job done well
·       Proven and successful track record as a team-player and collaborator in small working environments
·       Self-motivated and the ability to work independently while working towards common team goals
·       Highly organized and detail oriented with a passion to deliver quality results
·       Must be flexible and able to cope with constantly changing priorities
·       Demonstrated ability to stay informed of trends and new information
·       Excellent verbal and written communication skills, with experience translating technical concepts into user-friendly documentation
·       Highest levels of professionalism, confidence, personal values and ethical standards
·       Some travel for conferences and meeting with external partners may be necessary
·       Local travel in the Greater-Boston area for CRO engagement and management will be required
The description and requirements outlined above are general; additional requirements may apply.

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