Product Development Engineer

Description:

·       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.

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