LIFE CYCLE MANAGEMENT, STAFF ENGINEER

The Mentor Network is recruiting for a Life Cycle Management Staff Engineer, located in Irving, TX.
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.
nj.
om/.
Are you interested in joining a diverse and dynamic team that is helping improve patient care and drive innovation? Apply today! Key Responsibilities.
Responsible for presenting business-related issues or opportunities to the next management level.
Responsible to comply with all Federal, State, local, and Company regulations, policies, and procedures.
Identifies potential risks and challenges associated with product life cycle activities and develops mitigation strategies to address them proactively.
Responsible for the successful execution of product life cycle projects with a mid/high level of complexity and under minimal mentorship from the Life Cycle Manager, interacts with R&D, Quality, and Regulatory for life cycle and design change projects for legacy product lines.
Responsible to 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 Demonstrates independent understanding and application of core GMP fundamentals, including but not limited to.
Data Integrity (DI), Good Manufacturing Practices (GMP), and Good Documentation Practices (GDPs).
Ensures that all product life cycle activities enforce to relevant regulatory requirements, industry standards, and company policies.
Stay updated on regulatory changes and incorporate them into life cycle management practices.
Identifies opportunities for process optimization, cost reduction, and quality improvement throughout the product life cycle.
Implement improvements and standard methodologies to maximize efficiency and effectiveness.
Qualifications Education.
A minimum of a Bachelor's degree in Engineering or Manufacturing Operations is required.
Master's degree in Engineering or MBA is preferred.
Experience and Skills.
Required.
A minimum of 4 years’ experience in Operations within New Product Development, Quality, and/or Manufacturing, Supply, and Logistics with significant project and leadership skills is required.
Experience in the Medical Device or Diagnostics industry Ability to work effectively in a fast-paced, multifaceted environment and lead multiple projects simultaneously.
Must have proven successful completion of developing and leading several technical and/or business challenges.
Demonstrated ability to interact and lead, as applicable, with cross-functional/multi-disciplined teams is required.
Proven knowledge of risk management principles and their application to labeling, including hazard identification, risk assessment, risk control measures, and risk communication strategies.
Ability to interpret and apply labeling requirements for medical devices, including content, format, language, symbols, and placement.
Familiarity with labeling standards.
Familiarity with regulatory requirements and standards relevant to product life cycle management.
Proficiency with MS Office and Statistical Analysis Software is required.
Demonstrated track record of Project Management is required.
Ability to prioritize multiple commitments and technical problem-solving duties.
Ability to shift priorities according to changes in department/facility needs and open to different ideas/approaches.
Must have advanced proficiency in written and verbal communication.
Preferred.
Experience in a New Product Development project is preferred.
Demonstrated understanding of the healthcare-supervised industry Quality Systems and Change Control procedures is preferred.
Six Sigma/Process Excellence and/or Design Excellence experience is preferred.
Other.
This position is fully on-site 5 days a week in Irving, TX.
Required to travel up to 10% international or domestic.
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.
For more information on how we support the whole health of our employees throughout their wellness, career and life journey, please visit www.
areers.
nj.
om.