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Senior Engineer, Failure Analysis and Change Management - 2406201903W

Description

Auris Health, a member of Johnson & Johnson Family of Companies is recruiting for a Senior Engineer, Failure Analysis and Change Management! This position will be located in Santa Clara, 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/.

The Senior Engineer, Failure Analysis and Change Management is responsible for the hands-on technical analysis of sophisticated devices, components, hardware, and software to determine the root cause of failures or device issues. This is an individual contributor role for an inquisitive and driven team-player who will become intimately familiar with our medical devices and report out on findings to support process and product improvements. This is a meaningful role in the development and implementation of continuous improvement of our products and processes. Additionally, this individual will support new product and sustaining engineering change orders. This includes generating and submitting change order documentation through the appropriate review and approval process.

Are you interested in joining a diverse team delivering outstanding results to our customers? Apply now for this exciting opportunity!

Job Responsibilities:

• Collaborate with Engineers, Suppliers, Clinical Specialists, Field Service Engineers and Manufacturing personnel to facilitate a deep understanding of device functionality and failures and to perform in depth root cause analysis.

• Design and execute experiments and test methods to test theories to refine failure modes and determine root cause.

• First line of contact for resolution of Document Control related issues relevant to technical area of responsibility

• Act as liaison between R&D and document control to set strategy for Engineering Change Order implementation

• Acquire, analyze, and interpret information from data logs and various applications as well as perform physical (hands-on) deconstruction of devices as part of root cause analysis.

• Utilize failure analysis laboratory equipment, such as: optical digital microscopes, probes, X-ray systems, custom electrical test software, data log applications, and other test equipment and fixtures in support of failure analysis.

• Write formal analysis reports, resulting in clear and accurate messaging about analysis findings for a broad audience.

• Provide frequent verbal and written updates of work-in-progress for various meetings.

• Enhance investigation methodologies, develop and validate new test fixtures, and mentor the analysis team in the execution of those methods and tools.

Qualifications

Education:

• Bachelor of Science degree in Mechanical Engineering, Electrical Engineering, Computer Science or related field is required. Advanced Degree is preferred.

Experience and Skills:

Required:

• A minimum of 4 years of experience in a regulated environment (medical device, aerospace, defense, or similarly regulated industry)

• A minimum of 2 years of experience in a failure analysis role

• Experience using failure analysis laboratory equipment, such as: optical digital microscopes, probes, X-ray systems, custom electrical test software, data log applications, and other test equipment and fixtures.

• Experience working with ISO 13485 and 14971, GMP guidelines, FDA regulations

• Sophisticated analytical and problem-solving skills

• Proven track record of articulating risks and making critical decisions regarding product quality and quality system compliance

• Proficiency in root cause analysis tools and techniques (e.g. Hazard Analysis, FMEA, Fault Tree, Pareto diagrams, cause-and-effect diagrams, 5 whys, etc.)

• Tenacious attention to detail and consistency in work quality

• Proven understanding and ability in the use of statistical methods including trend analysis, Pareto, and other basic charting techniques

• Experience generating and implementing engineering change orders (ECO) in a quality management system

• Outstanding communication, presentation and interpersonal skills working within all levels of the organization

• An approachable individual who provides a high level of teamwork and multi-functional collaboration

• Flexibility to support changing assignments and priorities in an independent and reliable manner while maintaining a positive and collaborative demeanor

• Ability to work at the Santa Clara, CA site

• Ability to travel up to 10%

Preferred:

• Six-Sigma, ASQ CQE, or similar certifications

In the Bay Area, the anticipated base pay range for this position is $105,000 to $166,635.

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)). 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

• Work, Personal and Family Time - up to 40 hours per calendar year

For additional general information on Company benefits, please go to: https://www.careers.jnj.com/employee-benefits

This job posting is anticipated to close on Month / Day / 2024. 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.

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 .

Primary Location NA-US-California-Santa Clara

Organization Auris Health, Inc. (6267)

Travel Yes, 10 % of the Time

Job Function Quality Engineering

Req ID: 2406201903W