R&D Engineer

R&D Engineer

Location: Plymouth, MN

Job Type : W2 Contract.

Key Responsibilities:

Develop and confirm new methods and specifications for reprocessing of assigned devices

Performs complex hands-on and simulated testing for design verification and test method developments.

Review, edit, and create all engineering documentation related to assigned projects, such as technical reports, work instructions and method and process validation.

Leads basic engineering operations, and complex scientific evaluation on new products, technology concepts, and product development.

Applies complex algebraic and geometric formulas and advanced tool engineering data to develop product configurations.

Inspects and is responsible for testing of prototypes, tools, and fixtures after fabrication to ensure that they meet specifications.

Write verification and validation documentation and conduct required testing as needed to support FDA submissions

Perform reverse engineering to identify functional and performance requirements for reprocessed devices

Qualifications Preferred

• Previous experience in medical device is preferred

• Experience with 21 CFR part 820 and ISO 13485 requirements

• Experience or knowledge of DOE, FMEA, GMP, GDP, and QSR

• Other:

• Proficient in Microsoft Office and Microsoft Project

• Strong technical writing skills

• Ability to work within an ISO structured quality system

• Good planning, multi-tasking, and project management skills

• Consistent record of completing projects on time and accomplishing goals

• Ability to function independently as well as within a team

• Excellent written and oral communication skills

• Ability to balance multiple priorities in fast-paced environment

• 0-5% Travel percentage – with the United States or international.

• Education:

• Bachelor degree in Biomedical, Mechanical, Electrical Engineering or Equivalent

• Minimum of 2 years of increasingly responsible new product engineering experience.