Product Development Engineer


·       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.



Applying for a position?

We're currently in the process of changing up our internal HR systems. As a result, the links to apply for our current open positions are temporarily unavailable. We are working to get them online as soon as possible.

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

We look forward to getting to know you!

The MIS Team

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