Senior R&D Engineer at Johnson & Johnson in Irvine, CA

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 jnj.com

As guided by Our Credo, Johnson & Johnson is responsible to our employees who work with us throughout the world. We provide an inclusive work environment where each person is considered as an individual. At Johnson & Johnson, we respect the diversity and dignity of our employees and recognize their merit.

Job Function: R&D Product Development

Job Sub Function: R&D Process Engineering

Job Category: Scientific/Technology

All Job Posting Locations: Irvine, California, United States of America

Job Description:

Fueled by innovation at the intersection of biology and technology, we’re developing the next generation of smarter, less invasive, more personalized treatments.

Are you passionate about improving and expanding the possibilities of Cardiovascular? Ready to join a team that’s reimagining how we heal? Our Cardiovascular team develops leading solutions for heart recovery, electrophysiology, and stroke. You will join a proud heritage of continually elevating standards of care for stroke, heart failure and atrial fibrillation (AFib) patients.

Your unique talents will help patients on their journey to wellness. Learn more at https://www.jnj.com/medtech

We are searching for the best talent for a Senior R&D Engineer to support our Electrophysiology business. This role will work fully on-site in our Irvine, CA office.

The Senior R&D Engineer will identify, evaluate and drive the product development activities of medical devices for the healthcare industry in collaboration with the engineering development and product management teams. Strong focus will also be on leading the transition of new products from engineering into production. Provides engineering and design services to manufacturing and production engineering groups. Develops concepts, designs and details for machines, tools, fixtures, and products.

DUTIES & RESPONSIBILITIES:

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

• 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
• Responsible for communicating business-related issues or opportunities to next management level
• 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

EXPERIENCE AND EDUCATION:

• BS or MS Degree in Chemical, Mechanical, Electrical Engineering or equivalent
• Minimum of 4 to 6 years of increasingly responsible product/process engineering experience
• Experience with DOE, FMEA, GMP, and QSR

REQUIRED KNOWLEDGE, SKILLS, ABILITIES, CERTIFICATIONS/LICENSES and AFFILIATION:

• Proficient in Microsoft Office
• Strong statistical skills and knowledge of statistical software
• 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
• Solidworks knowledge required

Johnson & Johnson is an 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, disability, protected veteran status or other characteristics protected by federal, state or local law. We actively seek qualified candidates who are protected veterans and individuals with disabilities as defined under VEVRAA and Section 503 of the Rehabilitation Act.

Johnson & Johnson is committed to providing an interview process that is inclusive of our applicants’ needs. If you are an individual with a disability and would like to request an accommodation, external applicants please contact us via https://www.jnj.com/contact-us/careers. Internal employees contact AskGS to be directed to your accommodation resource.

Required Skills:

Preferred Skills: Analytical Reasoning, Coaching, Computerized Equipment Skills, Emerging Technologies, Engineering, Gemba Kaizen, Mechanical Equipments, Process Control, Process Oriented, Product Improvements, Purchasing, Research and Development, SAP Product Lifecycle Management, Situational Awareness, Teamwork, Technical Research, Technologically Savvy

The anticipated base pay range for this position is : $92,000.00 - $148,350.00

Additional Description for Pay Transparency: Subject to the terms of their respective policies and date of hire, employees are eligible for the following time off benefits:

Vacation –120 hours per calendar year

Sick time - 40 hours per calendar year; for employees who reside in the State of Colorado –48 hours per calendar year; for employees who reside in the State of Washington –56 hours per calendar year

Holiday pay, including Floating Holidays –13 days per calendar year

Work, Personal and Family Time - up to 40 hours per calendar year

Parental Leave – 480 hours within one year of the birth/adoption/foster care of a child

Bereavement Leave – 240 hours for an immediate family member: 40 hours for an extended family member per calendar year

Caregiver Leave – 80 hours in a 52-week rolling period10 days

Volunteer Leave – 32 hours per calendar year

Military Spouse Time-Off – 80 hours per calendar year

For additional general information on Company benefits, please go to: - https://www.careers.jnj.com/employee-benefits