Product Development Engineer

Description:

·       Participates as a leading team member in the development process anywhere from concept and ideation through commercialization for client companies.

Duties and Responsibilities

·       Leads development of concepts, prototypes, processes, and products from initial design to market release.  

·       Leads smaller projects where there is a clear path of execution and meeting the expected deliverables  

·       Assists in 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.  

·       Maintains detailed documentation throughout all phases of research and development.

·       Prepare project plans for basic projects that specify project phases, tasks, task interdependencies, durations, resource assignments, and costs.

·       Conduct and participate in meetings directly with clients. Proactively communicate with team to ensure an ongoing two-way exchange of information.

·       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.

·       Mentor junior engineers on technical development and project management as required.

·       Participates in brainstorming and design reviews.

·       Generates innovative concepts for new medical device designs to satisfy clinical requirements and meet or exceed customer expectations.

·       Participates in the organization and execution of interdepartmental activities to ensure the completion of projects on schedule and within budget constraints.

·       Conducts feasibility studies of the design to determine ability to function as intended.

·       Ability to generate and execute protocols and reports as needed to support validation activities, including Design Verification, IQ, OQ, PQ.

·       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+ years of medical device design and development experience is required, 5+ is preferred.

·       Familiarity with FDA QSR and ISO 13485 medical device regulations.

·       SolidWorks 3D CAD proficiency.

·       Knowledge of probability and statistics.

·       Familiarity with design for catheters and extrusions is required.

·       Familiarity with reinforced shaft, delivery systems, and steerable catheters is required.

·       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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If you would like to apply to one of our current openings, please e-mail your resume / application to jeff@midwestint.com, and include the position title in the subject line.

We look forward to getting to know you!

Best,
The MIS Team

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