Biosense Webster, Inc., a member of Johnson & Johnson's family of companies, is recruiting for an Research & Development Engineering Manager located 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 https://www.jnj.com/.
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Biosense Webster, Inc. is the global leader in the science of diagnosing and treating heart rhythm disorders. The company established its leadership in electrophysiology with the development of the first real-time, 3D cardiac mapping and navigation technology, as well as the first electrophysiology catheter. The introduction of the company's CARTO® 3 System in 2009 revolutionized 3D mapping technology by increasing the accuracy, speed, and efficiency of the cardiac ablation procedure.
Atrial fibrillation (AFIB) is a quivering or irregular heartbeat (arrhythmia) that can lead to blood clots, stroke, heart failure and other heart-related complications. 20 million people around the world suffer from AFIB each year.
Overview
The Research & Development Engineer will be supporting project teams in the development of electrophysiology catheters and systems at Biosense Webster. Project support includes overall design, requirement development, design for manufacturing, test method development, and product verification and validation testing.
In this exciting role as a Principal R&D Engineer, you will have responsibility for leading R&D teams through all activities required to design, develop, and commercially release groundbreaking Cardiovascular technologies. You will provide both technical leadership and project direction in collaboration with a global multi-national team including members with expertise from all areas involved in new product development. You will establish plans and ensure execution of those plans utilizing project management methodologies.
R&D Engineer IV (Staff) will be considered for candidates who are close to the requirements listed.
Key Responsibilities:
- Support engineering by researching, designing, developing, and testing according to established policies, procedures, government and compliance regulations, and customer requirements
- Establishes product goals to ensure share of market and profitability of products and/or services
- Works with R&D, Marketing, Manufacturing and Quality to identify and develop product specifications that meet customer needs around the world
- Develops and executes product development plans and programs. Both short and long range to ensure the profit growth and expansion of company products and or/services
- Ensures that necessary drawings, specifications, and testing are properly documented throughout the product development cycle
- Build prototypes and work with lab technicians to build prototypes
- Develop test fixtures and test methods
- Perform failure analysis using established analysis tools
- Documentation in a laboratory notebook and generation of formal test reports
- Data analysis of various system logs, including generators and Carto 3 system
- Interface with external vendors and internal cross functional partners
- Creation of work instructions, design drawings and procedures
- Works with identified physicians to capture new product information. May provide and set-up product evaluations
- Ensures effective control of development results to deliver the objective within designated budgets
- Communicates with next level management regarding business related issues or opportunities
- Advise management on technical direction for the program and department
- Other related duties maybe assigned
Qualifications
Education & Required Skills/Experience:
- Bachelor's degree in Biomedical Engineering or similar engineering discipline with minimum of (8) years of experience or Master's Degree in Biomedical Engineering or similar engineering discipline with a minimum of (6) years of experience
- Demonstrated ability to function as a technical contributor while leading a small team is required
Preferred Skills & Experience:
- Medical device Class III experience
- DFM experience
- Experience in a clinical environment with direct physician and staff engagement
- Experience in a pre-clinical testing environment
- Experience with extrusion, braiding and reflow processes
- Experience in the design and development of complex electro-mechanical systems
- Consistent track record working well in a team environment, learning from others, as well as mentoring and coaching team members
- In-depth knowledge of medical device regulations and external standards
- Excellent written & verbal communication and presentation skills
- Experience in system integration and system-level testing
- Comfortable with all phases of product development lifecycle including design, implementation, verification & validation testing, qualification, and transfer to manufacturing
- Mechanical analysis experience including statics, dynamics, kinematics, strength of materials and stress analysis
- Experience with statistical analysis and design of experiments (DOE)
- Experience with standard failure and root cause analysis methodology
- Experience and proficiency using SolidWorks as a design tool
- Familiarity with IEC-60601-1
- Six Sigma Certification
- Process automation experience a plus
- Windchill experience a plus
- Experience with programming tools such as R, Python, or Matlab 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 [$146,500] to [$185,000]
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 may be eligible to participate in Company employee benefit programs such as health insurance, savings plan, pension plan, disability plan, vacation pay, sick time, holiday pay, and work, personal and family time off in accordance with the terms of the applicable plans. Additional information can be found through the link below.
Eligible for benefits to include medical, dental, vision and time off as well as any others as provided for in the applicable Collective Bargaining Agreement.
For additional general information on company benefits, please go to: - https://www.careers.jnj.com/employee-benefits
Johnson & Johnson is an Affirmative Action and 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, or protected veteran status and will not be discriminated against on the basis of disability.
For more information on how we support the whole health of our employees throughout their wellness, career and life journey, please visit www.careers.jnj.com.
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