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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/.

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 Engineering manager will lead projects, mentor engineers, communicate within & across teams, and share your sophisticated knowledge of mechanical/biomechanical engineering and product design within the Research & Development design group to drive projects to completion. Your work will be focused on providing technical leadership in a fast-paced environment to a team that is enthusiastic about delivering quantitative results and creating a system that exceeds expectations of the customer.

We are seeking a highly motivated person who is passionate about product design, who will both inherit and add to a team, lead a newly scoped project, requiring you to both strengthen the team and contribute technically. In addition to team organization and project leadership, you will also actively work on assessing design methodologies and implementing innovative improvements to strengthen technical design excellence.

R&D Manager II (Sr. Manager) will be considered for candidates who exceed the requirements listed.

Key Responsibilities:

• Technical lead in new product development responsible for the design methodology, technical excellence, characterization, Verification and Validation activities, and commercialization for the R&D team

• Drive and collaborate innovative design solutions within a quick development cycle that support strategic intent and cost targets

• Collaborate with cross-departmental engineering teams and program management for system development and project planning. Key team interfaces include systems engineering, clinical and medical internal partners, clinical and medical external customers, external vendors, and internal manufacturing groups

• Establish and take ownership for overall test strategy for design verification and validation.

• Work closely with Manufacturing Engineering during development through design transfer and process development

• Closely collaborate with talent acquisition recruiters to hire and grow team according to budget and ensure a flawless employee onboarding

• Lead and support Risk Management activities, including FMEAs to ensure robust, safe, and reliable designs

• Ability to work independently with team engineers and technicians, with limited supervision at times

• Other 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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