A Minnesota based medical device client is looking to hire engineering talent onsite at their new facility in Maple Grove. This product development engineer will act as a leader on the engineering team as they work to develop complex catheter devices from concept and ideation through commercialization. We are looking for strong process development focused minds that have experience with root cause analysis, are comfortable juggling multiple priorities at once and have strong engineering fundamentals overall. This person will be interacting with clients so someone who is comfortable in that capacity is key as well.

Duties of Position:

• Leads development of concepts, prototypes, processes, and products from initial design to 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 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.
• Mentor junior engineers on technical development and project management as required.
• Leads brainstorming sessions 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.

Skills Needed:

• Bachelor's degree in Mechanical, or Biomedical Engineering is desired. In lieu of a degree, previous experience in a similar or exact role may be considered.
• 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.
• Knowledge of probability and statistics.
• Experience in design for catheters and extrusions is required.
• Experience in design for reinforced shaft, delivery systems, and steerable catheters is required.
• Depth of knowledge in one or more technical areas, for example laser/resistance welding.
• 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.

Salary of role depends on level brought in at but senior is around $70-90K annually bonus