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.
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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
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.
At Johnson & Johnson, we're on a mission to change the trajectory of health for humanity. That starts by creating the world's healthiest workforce. Through cutting-edge programs and policies, we empower the physical, mental, emotional and financial health of our employees and the ones they love.
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.
This job posting is anticipated to close on 2/28/2025. The Company may however extend this time-period, in which case the posting will remain available on https://www.careers.jnj.com to accept additional applications.
The anticipated base pay range for this position is $105,000 to $169,050