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:** R&D Mechanical Engineering **Job Category:** Scientific/Technology **All Job Posting Locations:** US331 CA Irvine - 31 Technology Dr **Job Description:** Johnson & Johnson MedTech, a member of Johnson & Johnson family of companies, is recruiting for a **Staff R&D Engineer** . This position is located in **Irvine, CA.** The J&J MedTech Companies have been working to make surgery better for more than a century. With substantial breadth and depth in surgical technologies, orthopedic and interventional solutions, we aspire to improve and enhance medical care for people worldwide. Together, we are working to shape the future of health through differentiated products and services. The Staff R&D Engineer will be supporting project teams in the development and manufacturing of electrophysiology products at Biosense Webster. Project support includes design for manufacturing (DFM), test method development, product/process verification and validation (V&V), manufacturing line activities, and various post launch product activities. **Key Responsibilities:** + Support engineering by researching, designing, developing, and testing according to established policies, procedures, government and compliance regulations, and customer requirements. + Support or lead quality improvement initiatives such as process and product characterizations that lead to continuous / cost improvements. + Support audits, CAPA / NC investigations, and post market requests. + Study specifications, engineering drawings, manufacturing instructions to resolve design problems related to material characteristics, dimensional tolerances, manufacturing process, and cost. + Perform design verification & validation (V&V) activities, process V&V activities, and supplier change requests. + Perform failure analysis using established analysis tools. + Write reports, work instructions, test methods and procedures. + Provide technical mentoring and directing work of less experienced engineers and technicians. + Interfaces with various cross-functional team members to ensure that designs meet quality objectives and long-term requirements. + Responsible for communicating business related issues or opportunities to next management level. + Performs other duties assigned as needed. **Qualifications:** **Required:** + Bachelor's degree in Biomedical Engineering or similar engineering discipline with minimum of 6 years of experience OR Master’s Degree in Biomedical Engineering or similar engineering discipline with a minimum of 4 years of experience. + Demonstrated ability to function as a technical contributor + Experience and proficiency using SolidWorks + Familiar with design control, engineering change orders (ECO), Corrective Actions and Preventive Actions (CAPA). **Preferred** : + Medical device Class III experience + In-depth knowledge of medical device quality and regulation systems and external standards, such as ISO 9001, ISO 13485, ISO 14971, FDA QSR. + Comfortable with all phases of product lifecycle including design, verification & validation, design transfer, post launch, and obsolescence. + Consistent track record leading projects, working well in a team environment, learning from others, as well as mentoring and coaching team members + Excellent written & verbal communication and presentation skills + Experience with manufacturing such as line qualifications, line transfer, and line duplication. + Experience with mechanical analysis including statics, dynamics, kinematics, strength of materials and stress analysis. + Experience with failure, root cause analysis methodology with strong analytical reasoning and problem-solving capabilities. + Experience in system integration and system-level testing. + Experience with statistical analysis and design of experiments (DOE) + Process automation experience a plus + Windchill experience a plus + Six Sigma Certification a plus **Other:** + This position is based in Irvine, CA and may require up to 20% (Domestic/International) travel. **The anticipated base pay range for this position is :** 105,000- 169,050 Additional Description for Pay Transparency: The Company maintains highly competitive, performance-based compensation programs. Under current guidelines, this position is eligible for an annual performance bonus in accordance with the terms of the applicable plan. The annual performance bonus is a cash bonus intended to provide an incentive to achieve annual targeted results by rewarding for individual and the corporation’s performance over a calendar/performance year. Bonuses are awarded at the Company’s discretion on an individual basis. Employees and/or eligible dependents may be eligible to participate in the following Company sponsored employee benefit programs: medical, dental, vision, life insurance, short- and long-term disability, business accident insurance, and group legal insurance. Employees may be eligible to participate in the Company’s consolidated retirement plan (pension) and savings plan (401(k)). This position is eligible to participate in the Company’s long-term incentive program. Employees are eligible for the following time off benefits: Vacation – up to 120 hours per calendar year Sick time - up to 40 hours per calendar year; for employees who reside in the State of Washington – up to 56 hours per calendar year Holiday pay, including Floating Holidays – up to 13 days per calendar year of Work, Personal and Family Time - up to 40 hours per calendar year Additional information can be found through the link below. http://www.careers.jnj.com/employee-benefits