Staff R&D Engineer, Life Cycle Management

At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at https://www.jnj.com

Job Function:

R&D Product Development

Job Sub Function:

Biomedical Engineering

Job Category:

Scientific/Technology

All Job Posting Locations:

Raritan, New Jersey, United States of America

Job Description:

We are searching for the best talent for a Staff R&D Engineer, Life Cycle Management located in Raritan, NJ.

Purpose: The R&D Staff Engineer will lead the R&D work-stream on life cycle management (LCM)/base-business projects, representing Ethicon Biosurgery R&D on a portfolio of design and process change projects in the field of Hemostats, Sealants and Adhesion Prevention.  This individual will work with other R&D scientists, engineers and cross functional partners in creating files to support existing product improvement, and other life cycle management activities, own Design History Files for LCM project Design and Process Changes, own Design Requirements Matrices for LCM project Design and Process Changes to ensure quality and regulatory compliance.

Under general direction and in accordance with all applicable federal, state and local laws/regulations and Corporate Johnson & Johnson, procedures and guidelines, this position will: 

• Lead the R&D work-stream on life cycle management (LCM)/base-business projects, representing Ethicon Biosurgery R&D on a portfolio of design and process change projects in the field of Hemostats and Sealants
• Own Design History Files for LCM project Design and Process Changes
• Own Design Requirements Matrices for LCM project Design and Process Changes
• Lead testing on competitive products, and develop strategies on competitive testing, prepare technical reports for use in marketing assets by commercial teams
• Lead activities for complaint handling for marketed products
• Participate in cross-functional project teams in a technical leadership role to drive the development of product requirements, concept generation, process identification, process scale-up and design control for hemostasis, tissue sealant, and adhesion prevention products
• Contribute inventions, new designs, or techniques to solve technical problems or improve existing products or processes.
• Work with in-house teams, cross J&J teams, and external collaborators including companies, universities and consultants to align project strategies with the regulatory, preclinical, and clinical strategies for innovative products to meet business objectives.
• Responsible for communicating business related issues or opportunities to next management level
• Responsible for following all Company guidelines related to Health, Safety and Environmental practices as applicable.
• For those who supervise or manage a staff, responsible for ensuring that subordinates follow all Company guidelines related to Health, Safety and Environmental practices and that all resources needed to do so are available and in good condition, if applicable
• Responsible for ensuring personal and Company compliance with all Federal, State, local and Company regulations, policies, and procedures
• Performs other duties assigned as needed

Education:

• A minimum of a MS in Chemistry (organic, analytical, or polymer), Materials, Mechanical, Biomaterials or Biomedical Engineering, or other relevant field with 7 years of experience in technical transfer and/or product discovery and development is required.
• Knowledge of preclinical regulatory requirements for FDA and notified bodies outside the US is preferred.

Required Skills & Experience:

• Experience executing Design Changes and Process changes
• Quality systems and Design Control knowledge pertaining to product development, and Design Changes in the medical devices field
• Experience with statistical software for study design and data analysis, eg, Minitab, SAS, SAS JMP, SPSS.
• Good technical writing, including auditable documentation, strong communication skills, project management skills, and ability to work Independently are essential

Preferred Skills & Experience:

• Han