Research And Development Engineer
1 week ago
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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