· Participates as a team member in the development process anywhere from concept and ideation through commercialization for client companies.
Duties and Responsibilities
· Develops new concepts from initial design to market release.
· Contribute to writing proposals for existing clients to achieve new deliverables within an existing phase or as a part of ongoing efforts.
· Designs and implements new methodologies, materials, machines, processes or products to bring concept to market, including essential product and process documentation.
· Contributes to execution of protocols and reports as needed to support validation activities, including Design Verification.
· Conducts feasibility studies of the design to determine ability to function as intended.
· Maintains detailed documentation throughout all phases of product development.
· Conduct risk analysis for products underdevelopment.
· Coordinates activities with outside suppliers and consultants to ensure the delivery of supplies or services needed to meet scheduled timelines.
· Participates in client meetings; Proactively communicates with team to ensure an ongoing two-way exchange of information.
· Participates in brainstorming and design reviews.
· Maintains standards of excellence in all Product Development processes.
· Any other duties as assigned.
Education, Experience, Skills
· Bachelor's degree in Mechanical, or Biomedical Engineering is desired. In lieu of a degree, previous experience in a similar or exact role will be considered.
· 3-5 years of medical device design and development experience is required
· Familiarity with FDA QSR and ISO 13485 medical device regulations.
· SolidWorks 3D CAD proficiency is required.
· Familiarity with design for catheters and extrusions is required.
· Experience designing and processing balloon catheters and balloon assemblies including troubleshooting and optimization.
· Knowledge of probability and statistics.
· Depth of knowledge in one or more technical areas, for example finite element analysis.
· Demonstrated ability to bring products from concept to market.
· Ability to interact with clients and companies in a professional manner.
· Customer focus with excellent communication skills, written and oral.