Johnson & Johnson MEDTECH is recruiting for a Research and Development (R&D) Engineer II, located in Plymouth, MN!
Become part of a premier organization dedicated to preserving our environment and growing cost savings for healthcare providers by offering reprocessed device solutions. In this exciting and critical role, you will lead and provide direction for new product introduction teams. Collaborate with core team members and key sponsors and partners to develop, validate, and gain regulatory clearance for reprocessed medical devices. Deliver the technical requirements to ensure a robust and on time product transfer. Inspire and support the development and identification of creative solutions and problem solving to deliver solutions to the customer.
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
Education
- Bachelor degree in Biomedical, Mechanical, Electrical Engineering or Equivalent
Experience and Skills:
Required
- Minimum of 2 years of increasingly responsible new product engineering experience
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.
Johnson & Johnson is an Affirmative Action and Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, or protected veteran status and will not be discriminated against on the basis of disability.
For more information on how we support the whole health of our employees throughout their wellness, career and life journey, please visit www.careers.jnj.com .]