Research And Development Engineer

1 week ago


Minneapolis, United States Intellectt Inc Full time

Role: R&D Engineer

Location: Plymouth, MN - 55442


Job Description:

We are seeking a dynamic and innovative R&D Engineer to join our team in Plymouth, MN. The ideal candidate will have 3+ years of experience in the medical device industry and will be responsible for supporting product development and innovation from concept through to commercialization. You will work closely with cross-functional teams including design, manufacturing, and quality to deliver cutting-edge solutions for our medical device products.


Key Responsibilities:

  • Design and develop medical device products, including conceptualization, prototyping, testing, and optimization.
  • Collaborate with cross-functional teams, including manufacturing, regulatory, and quality assurance to ensure products meet all safety, compliance, and functional requirements.
  • Conduct feasibility studies and simulations to assess product design viability and performance.
  • Develop and perform testing procedures to validate product performance and regulatory compliance.
  • Assist in the preparation of product documentation, including design specifications, validation protocols, and technical reports.
  • Work closely with vendors and suppliers to ensure the availability of quality materials and components for development.
  • Support the transfer of products from development to production, including ensuring manufacturing readiness.
  • Participate in the resolution of design and development issues as they arise, ensuring compliance with FDA and ISO standards.

Qualifications:

  • Bachelor’s degree in Biomedical Engineering, Mechanical Engineering, Electrical Engineering, or related field.
  • 3+ years of experience in product development within the medical device industry.
  • Hands-on experience with CAD software (SolidWorks, AutoCAD, etc.) for product design and modeling.
  • Knowledge of regulatory requirements (FDA, ISO 13485, etc.) and design control processes for medical devices.
  • Strong understanding of materials science, mechanical testing, and product validation techniques.
  • Experience with prototyping, testing, and statistical analysis.
  • Excellent communication skills with the ability to work in cross-functional teams.
  • Strong problem-solving skills and the ability to innovate under constraints.


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