Responsible for product development activities that encompass the design, testing, fabrication and validation of systems and devices as well as ancillary systems that may be necessary to meet company goals and objectives.
Applies intensive and diversified knowledge of engineering principles and practices to the research, development, design and evaluation of technical suitability of materials, components, assemblies, processes and/or equipment. Clearly communicates designs and all requisite requirements to support personnel both verbally and in writing.
Works to improve and expand company's capabilities to provide R&D services
Contributes to, develops and/or performs marketing and engineering specifications, feasibility plans/studies/reports, cost estimation/analysis, design reviews, risk and hazard analyses, FMEAs for Design/Process/Use, product verification and validation testing.
Builds and implements a detailed research/development work plan to fulfill company's project objectives.
Develops prototypes and processes based on company's available equipment, processes and/or specifies, procures suitable equipment for development reviews or coordinates supplier activities to support development.
Ensures appropriate communication processes are established within and across functional groups.
Communicates information related to quality management system effectiveness.
Attend animal studies as needed.
Collaborates with medical professionals to during all stages of development of prototypes/products including market/product specification development, pre-clinical and clinical testing of prototypes/products.
Other duties as assigned.
Training and Experience Required:
BS degree in Biomedical, Mechanical, or Biomedical Science or related degree.
10+ years medical design experience in medical device/clinical environment.
2-3 years of team lead or supervisor experience.
Ability to Function as the Project Leader from the Concept Phase through Market Release of Avantec Vascular projects.
Ability to work well under pressure and to meet multiple and occasional competing deadlines while maintaining a cooperative working relationship with other employees and supervisor.
Ability to attend human clinical cases and interact the hospital staff in a constructive and professional manner.
Knowledge of vascular interventional medical products and technologies, especially catheters, vascular access devices and guidewires.
Knowledge of medical device industry regulatory requirements including design and control practices, GMP’s and GLP’s.
Strong analytical and communications skills.
Out-of-the-box thinking, creativity and drive for excellence.
Proficient at basic MS word and Excel. Proficiency with SolidWorks/CAD.