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Senior Research and Development Engineer Project Manager 1 of 2

Plymouth, MN

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Sterilmed, a part of the CSS Group, member of the Johnsonand Johnson Family of companies is currently recruiting for a Senior Research and Development (R&D)nEngineer located in Plymouth, Minnesota The CSS Group consists of six diverse businesses includingnAdvanced Sterilization Products (ASP), Acclarent, Biosense Webster, Mentor, andnSterilmed. Sterilmed, a member of Johnson & Johnson's Family ofnCompanies, is a nationally recognized company that safely reprocessesnsingle-use medical devices for hospitals and surgery centers across thencountry. We take great pride in saving hundreds of millions of dollars for thenhealthcare system while simultaneously diverting thousands of tons ofnbiomedical waste from landfills. Medical device reprocessing is annFDA-regulated industry and is endorsed by the AHA, AORN, CMS and the JointnCommission. Position Summary: The Senior Research and Development (R&D) Engineer u2013nProject Manager will develop, validate, and gain regulatory clearance fornreprocessed medical devices for the healthcare industry. Strong focus on leading and drivingncollaborative cross-functional teams. Will lead the project team for the transition of new products from engineeringninto production through close cooperation. Essential Job Dutiesnand Responsibilities: Serve as project manager of a multifunctionalnteam to drive new product development activities from concept to launch.Develop and validate methods for reprocessing ofnassigned devices.Performs complex hands-on and simulated testingnfor design verification and test method developments.Reviews and edits all engineering documentationnrelated to assigned projects, such as technical reports, work instructions and methodnand process validation.Leads basic engineering operations, and complexnscientific evaluation on new products, technology concepts, and productndevelopment.Implements complex design concepts and ideasninto working blueprints and drawings.Studies specifications, engineering blueprints,ntool orders, and shop data and confers with engineering and shop personnel tonresolve design problems related to material characteristics, dimensionalntolerances, service requirements, manufacturing procedures, and cost.Applies complex algebraic and geometric formulasnand advanced tool engineering data to develop product configurations.Inspects and oversees testing of prototypes,ntools, and fixtures after fabrication to ensure that they meet specifications.Write verification and validation documentationnand conduct required testing as neededFamiliar with all aspects of medical devicenproduct development, including design, verification and validation, FDAnsubmission, and design transfer into manufacturing.Perform reverse engineering to identifynfunctional and performance requirements for reprocessed devicesOversee design and build of new components andnassembly toolingPerform testing and inspection functionsnincluding forensics and root cause analysisAssist regulatory compliance efforts andnverification and documentation related to engineering standardsAuthor, revise, train, and provide support fornproduction work instructions.Identify new processing needs and performncontinuous improvement to support sustaining effortsPerform reverse engineering to identifynfunctional and performance requirements for reprocessed devicesProficient in the investigation and managementnof CAPAu2019s, root cause analysis, complaints, and escalations.Lead and facilitate process improvementnactivitiesRole may include project and team managementnresponsibilitiesCommitted to building a positive cultureOther responsibilities may be assigned & notnall responsibilities listed may be assigned QualificationsBachelor degree in Engineering is required.An Engineering degree in one of the following isnpreferred (Chemical, Mechanical, Electrical Engineering, Biomedical Engineering)4 years related engineering experience isnrequiredMinimum of 2 yearsu2019 experience leading complexnprojects and a multi-functional project team is preferred. Prior experience in the medical device industrynis preferredExperience with FDA submissions, writing andnconducting test plans, protocols and reports is preferredProficient in Microsoft Office is required.Proficient in Microsoft project is required Strong statistical skills and knowledge ofnstatistical software is preferredExperience with DOE, FMEA, GMP, and QSR isnpreferred.Ability to work within an ISO structured qualitynsystem is required.Knowledge of engineered materials andnfabrication methods is required.Good planning, multi-tasking, and projectnmanagement skills is requiredDemonstrated track record of completing projectsnon time and accomplishing goals is requiredAbility to function independently as well asnpart of a team is requiredExcellent written and oral communication skillsnis requiredAbility to manage multiple priorities innfast-paced environment is requiredUp to 10% travel both domestic and internationalnis required Do you strive to join an outstanding team that is dynamicnand ever-changing? Is career growth and opportunity appealing to you? Apply tonthis opportunity today. Johnson & Johnson Family of Companies are equalnopportunity employers, and all qualified applicants will receive considerationnfor employment without regard to race, color, religion, sex, sexualnorientation, gender identity, genetic information, national origin, protectednveteran status, disability status, or any other characteristic protected bynlaw.n

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