Senior Product Development Engineer

2 weeks ago

Minneapolis, United States Cypress HCM Full time
Job DescriptionJob DescriptionA medical device company is looking for a Senior Product Development Engineer in Maple Grove, Minnesota. This person will lead development of concepts, prototypes, processes, and products from initial design to release of catheter related products. This role is 100% onsite and will begin as a contract.Duties of role:
  1. Leads smaller projects where there is a clear path of execution and meeting the expected deliverables
  2. Assists in writing proposals for existing clients to achieve new deliverables within an existing phase or as a part of ongoing efforts.
  3. Designs and implements new methodologies, materials, machines, processes or products to bring concept to market, including essential product and process documentation
  4. Maintains detailed documentation throughout all phases of research and development
  5. Prepare project plans for basic projects that specify project phases, tasks, task interdependencies, durations, resource assignments, and costs.
  6. Conduct and participate in meetings directly with clients.
  7. Proactively communicate with team to ensure an ongoing two-way exchange of information.
  8. Conduct risk analysis for products under development.
  9. Coordinates activities with outside suppliers and consultants to ensure the delivery of supplies or services needed to meet scheduled timelines.
  10. Mentor junior engineers on technical development and project management as required.
  11. Leads brainstorming sessions and design reviews.
  12. Generates innovative concepts for new medical device designs to satisfy clinical requirements and meet or exceed customer expectations.
  13. Participates in the organization and execution of interdepartmental activities to ensure the completion of projects on schedule and within budget constraints.
  14. Conducts feasibility studies of the design to determine ability to function as intended.
  15. Ability to generate and execute protocols and reports as needed to support validation activities, including Design Verification, IQ, OQ, PQ.
  16. Maintains standards of excellence in all Product Development processes
What We Are Looking For:
  1. Bachelor's degree in Mechanical, or Biomedical Engineering
  2. 8-10 years of medical device design and development experience
  3. Familiarity with FDA QSR and ISO 13485 medical device regulations
  4. SolidWorks 3D CAD proficiency.
  5. Knowledge of probability and statistics
  6. Experience in design for catheters and extrusions
  7. Experience in design for reinforced shaft, delivery systems, and steerable catheters
  8. Depth of knowledge in one or more technical areas, for example laser/resistance welding
  9. Demonstrated ability to bring products from concept to market
  10. Ability to interact with clients and companies in a professional manner.
  11. Customer focus with excellent communication skills, written and oral
Hourly rate of $45-65 depending on experience level

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