Johnson & Johnson Biosense Inc a member of the Johnson & Johnson Family of Companies is recruiting for a Staff Quality Engineer, Life Cycle Management (LCM). This position will be located in Irvine, CA.

A pre-identified candidate for consideration has been identified. However, all applications will be considered.

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/.

• Identifying systemic product issues from post-market surveillance data and/or customer feedback
• Leading root cause investigations into identified product issue(s)
• Conduct Failure analysis into identified product issue(s)
• Developing models to replicate product issues
• Developing solutions to eliminate product issues
• Developing test methodology to verify proposed solutions eliminate the product issues
• Facilitate cross-functional collaboration with other teams in Biosense Webster Inc. to validate and implement solutions to production lines
• Analyzing post-market surveillance data to confirm efficacy of complaints
• Communicating project progress to management and, where applicable, other functional teams within Biosense Webster Inc.
• Writing engineering reports, protocols, work instructions, and test methods.
• Studying engineering specifications, blueprints, test data, manufacturing data, etc. and carrying the understanding forward to solve systemic product issues.
• Performing tolerance stack-ups when required by the project.
• Developing customer requirements and product specifications with validated test methods
• Interfacing between external vendors and core team
• Traveling to customer sites and manufacturing sites, domestic and international, to gather VOC, perform testing and/or perform troubleshooting activities
• Helping develop system verification and validation plans.
• Providing technical mentoring to less experienced engineers and technicians
• Purchasing or designing equipment for product issue analysis that also meet 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.
• Other related duties may be assigned.

• Bachelor's or equivalent University degree is required; a focused degree in Engineering or a Scientific discipline is preferred.

• A minimum of 6 years of Quality, Manufacturing, or Research and Development experience in the Medical Device industry.
• Experience with analytical tools, such as: MATLAB, Finite Element Analysis, heat-transfer, and/or related.
• Hands-on experience developing and building tools for concept feasibility testing, production, verification and validation testing, and automat testing.
• Ability to be a project leader on multi-functional teams.
• Collaborative teammate with strong communication skills, written and verbal.
• Ability to solve complex problems.
• Ability to work in a prototype lab with possible visits to clean room.
• Ability to define problems, collect and analyze data, establish facts and draw conclusions and recommendations.

• Knowledge and experience in product development processes.
• Experience with catheter design or any medical device.
• Experience with statistical analysis and design of experiments (DOE).
• In-depth knowledge of material and metals used in design of medical devices.
• Knowledge of system engineering methodologies.
• Prior experience developing a systems engineering department/team.
• American Society for Quality (ASQ) certification, Six Sigma experience, and/or knowledge of Process Excellence tools is desirable.
• Ability to use broad knowledge of regulatory, technical, and business requirements to conduct due diligence assessments.
• Ability to apply project management skills to ensure fulfillment of new product development requirements.
• Ability to develop and implement Quality standards.
• In-depth knowledge of Quality and operations systems & processes, including GMP & QSR requirements for medical devices.
• Demonstrated auditing and problem-solving skills.
• In-depth knowledge of leading-edge Quality Engineering, design control, and verification and validation (V&V) tools & methodologies.

• May require up to 10% domestic & international travel.
• The anticipated base pay range for this position is $91,000 to $147,200.
• In California Bay Area - The anticipated base pay range for this position is $105,000 to $169,050.

• 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)).
• 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. https://www.careers.jnj.com/employee-benefits