Johnson & Johnson Careers

R&D ENGINEER 2

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


Job Description

Requisition ID: 1229180524

Sterilmed, a part of the CSS Group, member of the Johnson and Johnson Family of companies is currently recruiting for a R&D Engineer II 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 at a time 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.

The Research and Development (R&D) Engineer will:

  • Project Manager will develop, validate, and gain regulatory clearance for reprocessed medical devices for the healthcare industry. Strong focus on leading and driving collaborative cross-functional teams Will lead the project team for the transition of new products from engineering into production through close cooperation.
  • Serve as project manager of a multifunctional team to drive new product development activities from concept to launch.
  • Develop and validate methods for reprocessing of assigned devices.
  • Performs complex hands-on and simulated testing for design verification and test method developments.
  • Reviews and edits 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.
  • Implements complex design concepts and ideas into working blueprints and drawings.
  • Studies 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.
  • Applies complex algebraic and geometric formulas and advanced tool engineering data to develop product configurations.
  • Inspects and oversees 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
  • 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
  • Oversee design and build of new components and assembly tooling
  • 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
  • Proficient in the investigation and management of CAPA’s, root cause analysis, complaints, and escalations.
  • Lead and facilitate process improvement activities
  • Role may include project and team management responsibilities
  • Committed to building a positive culture
  • Other responsibilities may be assigned & not all responsibilities listed may be assigned
  • POLICIES: Know and follow Sterilmed and Johnson & Johnson policies and procedures related to work activities performed in area of responsibility
  • TRAINING: Complete training in area of responsibility within allowed time-period. Training is required for changes in existing policies & procedures, for new assignments and for implementation of new policies & procedures. Complete required periodic re-training in areas such as environmental health & safety
  • SAFETY: Follow all company safety policies & other safety precautions within work area. Promote safety to all associates that enter the work area

Qualifications
Qualifications:
 
  • Bachelor degree in Chemical, Mechanical, Electrical Engineering, Biomedical Engineering, or equivalent.
  • A minimum of 2 years related experience engineering experience required
  • Minimum of 1-year project management experience preferred – leading complex projects and a multi-functional project team
  • Prior experience in the medical device industry is preferred
  • Experience with FDA submissions, writing and conducting test plans, protocols and reports
  • Proficient in Microsoft Office
  • Proficient in Microsoft project
  • Strong statistical skills and knowledge of statistical software
  • Experience with DOE, FMEA, GMP, and QSR
  • Ability to work within an ISO structured quality system
  • Knowledge of engineered materials and fabrication methods
  • Good planning, multi-tasking, and project management skills
  • Demonstrated track record of completing projects on time and accomplishing goals
  • Ability to function independently as well as part of a team
  • Excellent written and oral communication skills
Ability to manage multiple priorities in fast-paced environment

Primary Location
United States-Minnesota-Plymouth
Organization
Sterilmed, Inc. (6215)
Job Function
R&D Engineering (R&D)
Requisition ID
1229180524