Johnson & Johnson, Sterilmed is recruiting for a Senior R&D Engineer – Project Manager located in Plymouth, MN
The Johnson & Johnson Medical Devices Companies have been working to make surgery better for more than a century. With substantial breadth and depth in surgical technologies, orthopedic and interventional solutions, we aspire to improve and enhance medical care for people worldwide. Together, we are working to shape the future of health through differentiated products and services.
Position Summary: Become part of a world-class organization dedicated to improving 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.
This Senior R&D Engineer will have the opportunity to lead a team and get exposure to a large range of new and exciting technologies in collaboration with other J&J companies. You will be providing a great benefit to hospitals and the environment as a part of this growing industry of reprocessed medical devices while growing project management skills.
Major Duties and Responsibilities:
• Serve as the project lead of a multifunction team to drive new product development activities from concept to FDA submission.
• Develop and run the project schedule and lead team meetings and presentations.
• Create product specifications and project plans.
• Develop and validate processes and equipment for assigned new reprocessed devices.
• Perform complex hands-on simulated use and testing for proposed reprocessed devices.
• Author validation documentation for assigned projects, such as technical reports, work instructions, qualifications and validations.
• Familiar with all aspects of medical device product development, including design, verification and validation, FDA submission, and design transfer into manufacturing.
• Responsible for design and build of test devices.
• Perform design verification testing and author reports.
• Partner with multi-functional team members including marketing, quality, regulatory compliance, supply chain, and others.
• Author, revise, train, and provide support for production work instructions.
• Committed to building a positive culture
• Other responsibilities may be assigned & not all may be listed
Required Minimum Education:
Bachelor degree in Biomedical, Mechanical, Electrical Engineering or Equivalent
• Formal Certification in Project Management is preferred
Minimum of 5 years of increasingly responsible new product engineering experience
• Previous experience in medical device is strongly preferred
• Previous experience in Project Management is preferred
• Experience with DOE, FMEA, GMP, GDP, and QSR
Required Knowledge, Skills and Abilities:
• Experience with 21 CFR part 820 and ISO 13485 requirements
• 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
At Johnson & Johnson, we’re on a mission to change the trajectory of health for humanity. That starts by creating the world’s healthiest workforce. Through cutting-edge programs and policies, we empower the physical, mental, emotional, and financial health of our employees and the ones they love. As such, candidates offered employment must show proof of COVID-19 vaccination or secure an approved accommodation prior to the commencement of employment to support the well-being of our employees, their families and the communities in which we live and work.
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.
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.