Sr R/D Engineer
2300 Berkshire Lane North Minneapolis, MN 55441 US
Additional position detail from the manager below:
- Can you please confirm your top 3 skills sets required? Design Verification & Validation, Design of Experiments, Requirement Flow/Spec Setting
- What is your target years of experience? >= 4 years of experience
The Sr. R&D Engineer works collaboratively with a team to design, develop and launch medical devices as well as support existing products. This position may support multiple projects through different stages of the product development cycle. This position may analyze, troubleshoot and provide technical skills during research, product development and/or clinical trials. This position requires collaborative interaction with Manufacturing, Quality, Marketing, Regulatory Affairs and other key functions to achieve business deliverables. This role is an individual contributor within the company's Peripheral Vascular business.
A Day in the Life:
- Assist in the development of new combination products and components.
- Prototype, test, and iterate designs used in the medical field
- Design, develop, analyse, troubleshoot and provide technical skills during research and/or product development.
- Support the development and integration of new technologies into product offering.
- Provide assistance to interdepartmental team for new product introduction.
- Take an active role in early-stage design control activities leading to a first in man study (innovation, proof of principle, product development, process development, and equipment development) such that a robust pilot line that is scaleable and transferable to commercial manufacturing is achievable.
- Document research and development process through lab notebooks, engineering characterization studies, and test reports.
- Work with Regulatory Affairs (RA) to compile US and OUS regulatory submissions. Assist RA with answering subsequent questions from regulatory bodies.
- Design and develop new test methods and equipment specific to new products. Train technicians in new processes.
- Create document change orders (CO’s) for design, materials, and process documentation.
- Work with Regulatory, Preclinical, Quality, and Manufacturing departments to create product performance, design, and manufacturing specifications.
- Perform competitive product analyses.
- Work with patent counsel to file and evaluate intellectual property.
- Interact frequently with all departments within organization and occasionally with external physicians, consultants, and vendors.
- Minimum travel requirement of 10%.
- Bachelors Degree in Engineering
- Design Verification and Validation
- Experience with CAD software, preferably SolidWorks.
- Product design, development, changes and improvements
Nice To Have
- Investigation and root cause analysis skills
- Technical writing knowledge. Organization and Communication skills
- Process validation knowledge close
- Project management experience
- Test Method Development
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