Pervasis is seeking Engineering personnel. Qualified candidates will be responsible for the engineering of devices related to the production of our company’s cell based products.
Essential Duties and Responsibilities
• Develop new system, methods and concepts to support the Pervasis minimally invasive/injectable programs
• Design devices and components including generation of required documentation and detail drawings
• Support device prototyping and system/device testing, offering appropriate mechanical skills and experience in
a hands-on manner
• Provide thorough knowledge of manufacturing methods and processes including injection-molding, extruding,
machining and thermoforming
• Design and evaluate systems giving consideration to design for manufacturbility principles
• Develop effective test protocols and execute or oversee testing as defined by these and other approved
Pervasis protocols
• Plan and/or perform method and/or process qualification/validation studies
• Prepare technical reports, summaries, protocols, statistical and quantitative analyses
• Prepare devices and materials for animal experimentation
• Maintain detailed and accurate laboratory records
• Work within requirements of a medical device quality system
• Interact with physicians including interventional radiologists, interventional cardiologists and vascular surgeons
to establish design parameters, evaluate concepts and plan studies
• Work successfully in collaboration with cell biologists on development, requirements and limitations of a cell
based product
• Initiate detailed literature searches in order to maintain familiarity with current scientific literature pertaining to
delivery devices, visualization techniques, vascular biology and cell-based methodologies/techniques as
necessary to successfully enhance or complete assigned projects
Education/Experience
• B.S. and/or M.S. in Mechanical Engineering or equivalent
• 7 – 10 years in medical device design/development
• Successful product design history including experience with fluidics and mechanisms
• Vascular, catheter, cardiology and/or radiology products background preferred
• Demonstrated ability to develop test/validation procedures and protocols, oversee/perform testing and author proper test reports
• Statistical analysis and principles experience
• Effective interaction skills with physicians, scientists, manufacturing, regulatory and quality personnel
• Design experience with injection-molded plastics, extruded polymers and machined components
• Working knowledge of common and specialty engineering materials
• Biological and “crossover” product exposure desirable
• “Hands-on” prototyping, model shop and/or machine shop experience a bonus
Bob Higgins
Graham Gardner, M.D.