Senior R&D Engineer

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