Johnson & Johnson Careers

Senior Scientist, R&D Sterility Assurance

Cincinnati, Ohio
Biology


Job Description

Requisition ID: 3975190617

Ethicon is currently recruiting for a Senior Scientist, R&D Sterility Assurance, located in Cincinnati, OH.


Ethicon, part of the Johnson & Johnson Medical Devices Companies, has made meaningful contributions to surgery for more than 60 years from creating the first sutures, to revolutionizing surgery with minimally invasive procedures. Our continuing dedication to Shape the Future of Surgery is built on our commitment to help address the world's most pressing health care issues and improve and save more lives. Through Ethicon's surgical technologies and solutions including sutures, staplers, energy devices, trocars and hemostats and our commitment to treat serious medical conditions like obesity and cancer worldwide, we deliver innovation to make a life-changing impact. For more information, visit www.ethicon.com.


The Senior Scientist will semi-autonomously develop strategies, protocol and project plans for the sterilization of medical devices, leads the execution of protocols and generates completion reports. Working under minimal supervision the Senior Scientist will conduct research and contribute to the origination and direction of experiments and new methodologies, prioritize tasks according to broad project goals and support technical consultants as needed.

 

The Senior Scientist will perform the following:

  • Apply scientific principles to new products/technology concepts using creating thinking and innovative techniques
  • Design, develop and validate new innovative test methods for characterizing medical devices and biomaterials
  • Effectively prioritize and manage multiple activities simultaneously
  • Develop test protocols, carry out experiments (including design of equipment/fixtures as needed), analyze test results, and prepare technical completion reports
  • Work with project teams to provide sterilization strategies aimed at supporting product development and regulatory submissions
  • Collaborate with associates of diverse technical and non-technical backgrounds to achieve desired project outcomes
  • Identify and mitigate risks associated with new product development activities in area of responsibility
  • Develop departmental and/or franchise-level procedures in support of company policies
  • Ensure deliverables comply with company and external standards
  • Maintains strong working knowledge of terminal sterilization technologies including radiation, ethylene oxide and moist heat
  • Maintains working knowledge of relevant standards and compendial methods for sterilization and sterility assurance (e.g. AAMI, ISO, ASTM, USP/EP/JP, etc.)


Qualifications
  • Experience in conducting audits of sterilization service providers and ancillary services impacting sterilization
  • A minimum of five (5) years direct experience with medical device and/or diagnostic sterilization processes is required with experience at the Scientist/Engineer level or equivalent external experience
  • B.A./B.S. in life science, engineering, or related scientific/technical discipline required (e.g. biology, microbiology, physics, etc.)
  • MS degree preferred
  • Knowledge and experience in national/international standards in quality management, sterilization methods, microbiology and sterility assurance
  • Demonstrate results in Quality Control, Compliance, and Regulatory
  • Experienced in working with (or leading) multi-functional project teams for the design and validation of sterilization processes for medical products
  • Able to apply strategic thinking & big picture orientation
  • Project management desired
  • Knowledge of statistical techniques for data management, presentation and analysis
  • Customer focus (internal & external) and strong business acumen
  • Strong written & verbal communication skills
  • Results-driven and a sense of urgency
  • Understanding of information technology in order to allow utilization of new technologies to meet business objectives
  • Quality and compliance focus
  • Personal computer software – Windows: word processing, project planning, presentation, e-mail, flow charts & spreadsheet software

 
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

Primary Location
United States-Ohio-Cincinnati-
Organization
Ethicon Endo Surgery Inc (6041)
Job Function
Biology
Requisition ID
3975190617