Job Function: R&D Product Development
Job Sub Function: R&D Mechanical 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
Staff Mechanical Engineer, R&D, to support our Electrophysiology business. This role will work onsite in our
Irvine, CA officeThe Staff Mechanical Engineer, R&D will be supporting project teams in the development of electrophysiology catheters and systems at Biosense Webster and provides advice and mentorship to less experienced personnel. Project support includes overall design, requirement development, design for manufacturing, design transfer, test method development, and product verification and validation testing.
Key Responsibilities:- Lead design transfer of next-generation EP catheter platforms while strictly ensuring compliance with FDA and ISO medical device standards.
- Lead the design of new or existing components and/or devices while ensuring that all design requirements are met.
- Develop customer requirements and product specifications with validated test methods
- Support or lead quality improvement initiatives such as process and product characterizations that lead to continuous / cost improvements.
- Study specifications, engineering blueprints, tool orders, and shop data and confer with engineering and shop personnel to resolve design problems related to material characteristics, dimensional tolerances, service requirements, manufacturing procedures, and cost.
- Interface between external vendors and core team.
- Expected to present project work across management levels and to customers and author scientific publications and patents in support of key technologies. Expected to write reports, work instructions, test methods and procedures.
- Travel to customer sites, domestic and international, to gather VOC, perform testing and/or perform troubleshooting activities.
- Responsible for performing design reviews and pre-validation assessments to ensure the safe and environmentally sound processes and designs.
- Provide technical mentoring to less experienced engineers and technicians
- Responsible for the purchase or design of equipment that meets health, safety and environmental standards set by the company.
- Responsible for ensuring personal and company compliance with all Federal, State, local and company regulations, policies and procedures for Health, Safety and Environmental compliance.
Qualifications- A Bachelor's Degree in Mechanical (preferred) or Biomedical Engineering with a minimum of 8 years of experience, or a Master's degree with minimum of 6 years of experience, or PhD and 4 years of industrial experience is required.
- 3 years' experience in early-stage (pre-design freeze) catheter and/or cardiovascular device development is preferred.
- Minimum 1 year as team or project technical lead.
- Experience with CAD software such as SolidWorks is required.
- Strong understanding of engineering materials, component selection, and design for reliability and manufacturability is required.
- Knowledge and experience in product development processes is preferred.
- Strong understanding of data analysis and statistics including design of experiments, Gage R&R, capability, etc. is a strong plus.
- Must possess strong communication skills, written and verbal
- Ability to speak Spanish is preferred
- Ability to solve complex problems
- Ability to travel up to 25% domestic and international is required
Required Skills:Preferred Skills:Business Case Modeling, Coaching, Critical Thinking, Design Thinking, Feasibility Studies, Mechanical Engineering, Problem Solving, Process Oriented, Product Design, Product Development, Project Management Methodology (PMM), Project Support, Research and Development, SAP Product Lifecycle Management, Technical Credibility, Technical Writing, Technologically Savvy
The anticipated base pay range for this position is :$109,000.00 - $174,800.00
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
For additional general information on Company benefits, please go to: - https://www.careers.jnj.com/employee-benefits
Volunteer Leave - 32 hours per calendar year
Military Spouse Time-Off - 80 hours per calendar year
