Participates as a team member in the development process from concept and ideation, through commercialization for client companies. The balloon focused product development engineer is responsible for the execution of the Balloon Business Unit strategic plan. This individual will create manufacturing processes, component specifications, and design control documentation in support of internal and client project needs. In addition, this individual will interface with internal and external customers as the subject matter expert in Balloon focused device technologies. MIS is looking for someone who is driven and exceptionally organized with strong analytical skills that can work independently to build a world class product offering from the ground up.
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 under development.
· 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.
· 3-5years of medical device design and development experience is required
· Familiarity with FDA QSR and ISO 13485 medical device regulations.
· SolidWorks3D 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.