Johnson & Johnson Careers

Senior R&D Engineer, Project Lead

Plymouth, Minnesota
R&D Engineering (R&D)


Job Description

Requisition ID: 5753190128

Sterilmed, a part of the CSS Group, member of the Johnson and Johnson Family of companies is currently recruiting for a Senior Research and Development Engineer, Project Manager located in Plymouth, Minnesota. The CSS Group consists of six diverse businesses including Advanced Sterilization Products (ASP), Acclarent, Biosense Webster, Mentor, and Sterilmed.

 

Sterilmed, a member of Johnson & Johnson's Family of Companies, is a nationally recognized company that safely reprocesses single-use medical devices for hospitals and surgery centers across the country. We take great pride in saving hundreds of millions of dollars for the healthcare system while simultaneously diverting thousands of tons of biomedical waste from landfills. Medical device reprocessing is an FDA-regulated industry and is endorsed by the AHA, AORN, CMS and the Joint Commission.    

 

Become part of a world-class organization dedicated to improving the sustainability and cost saving goals of healthcare providers. In this role, you will provide leadership and direction for New Product Introduction teams. Partner with multi-functional areas to develop, validate, and gain regulatory clearance for reprocessed medical devices. Deliver the technical requirements to ensure a robust technology transfer. Lead a technical team that supports business base and critical issues subjects that require technical solutions. Inspire and support the development and identification of creative solutions and problem solving.

Responsibilities:

  • Serve as project manager of a multifunction team to drive new product development activities from concept to launch
  • Develop and validate methods for reprocessing of assigned devices.
  • Perform complex hands-on and simulated testing for design verification and test method developments
  • Review and edit all engineering documentation related to assigned projects, such as technical reports, work instructions and method and process validation
  • Lead basic engineering operations, and complex scientific evaluation on new products, technology concepts, and product development
  • Implements complex design concepts and ideas into working blueprints and drawings.
  • Study specifications, engineering blueprints, tool orders, and shop data and confers with engineering and shop personnel to resolve design problems related to material characteristics, dimensional tolerances, service requirements, manufacturing procedures, and cost
  • Write verification and validation documentation and conduct required testing as needed
  • Familiar with all aspects of medical device product development, including design, verification and validation, FDA submission, and design transfer into manufacturing.
  • Perform reverse engineering to identify functional and performance requirements for reprocessed devices
  • Perform testing and inspection functions including forensics and root cause analysis
  • Assist regulatory compliance efforts and verification and documentation related to engineering standards
  • Author, revise, train, and provide support for production work instructions.
  • Identify new processing needs and perform continuous improvement to support sustaining efforts
  • Perform reverse engineering to identify functional and performance requirements for reprocessed devices
  • Committed to building a positive culture
  • Other responsibilities may be assigned & not all responsibilities listed may be assigned




Qualifications

  • A minimum of a Bachelor’s degree in Engineering is required
  • An Engineering degree in one of the following: Chemical, Mechanical, Electrical Engineering or Biomedical Engineering is preferred
  • Minimum of 5 years of product and/or process engineering experience is required
  • Ability to work within an ISO structured quality system is required
  • Proficient in Microsoft Office is required
  • Proficient in Microsoft Project is preferred
  • Experience in the medical device industry is preferred
  • Experience with DOE, FMEA, GMP, and QSR is preferred
  • Experience with 21 CFR part 820 and ISO 13485 requirements is preferred
  • Statistical skills and knowledge of statistical software is preferred
  • Knowledge of engineered materials and fabrication methods is preferred
  • Experience leading projects in a matrixed environment is preferred
  • Project Management Professional Certification is preferred
  • This position is located in Plymouth, MN and may require up to 10% travel

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.


IND6



Primary Location
United States-Minnesota-Plymouth-
Organization
Sterilmed, Inc. (6215)
Job Function
R&D Engineering (R&D)
Requisition ID
5753190128