Manufacturing NPI Engineer

Johnson & Johnson is recruiting for a Manufacturing Engineer NPI located in Santa Clara, CA.

Robotics & Digital Solutions, part of the Johnson & Johnson family of companies, is recruiting for a Manufacturing Engineer, NPI, located in Santa Clara, CA. Robotics & Digital Solutions is part of Ethicon, Inc., a global leader in surgery with products and solutions found in almost every operating room around the world. Ethicon has made significant contributions to surgery for more than 100 years from creating the first sutures, to revolutionizing surgery with minimally invasive procedures. Our continuing dedication to Shape the Future of Surgery is built on our commitment to help address the world's most pressing health care issues and improve and save more lives. Through Ethicon's surgical technologies and solutions including robotics, digital solutions, sutures, staplers, energy devices, trocars and hemostats and our commitment to treat serious medical conditions like obesity and cancer worldwide, we deliver innovation to make a life-changing impact. For more information, visit www.ethicon.com.

The Manufacturing Engineer NPI is responsible for acting with high drive and urgency to launch products to market as an individual contributor, on a cross functional team, conducting various assignments in cooperation with direction of team & team leader. Scope of responsibility included specifying, procuring, qualifying, validating, troubleshooting, and maintaining process and test equipment and manufacturing and test procedures needed for robotic assembly and test, dispensing, and/or packaging components and/or products. Supports investigations to determine root cause of failures, presents results, and proposes corrective and preventative actions as required. Uses capabilities, such as Lean/Six Sigma, DFx, SPC, etc, to improve company knowledge, products and processes. Collaborates and interacts with other company engineering teams, including teams representing R&D, Product Quality, Regulatory, and Supplier Quality. Provide engineering, risk assessment, and statistics support in the development and maintenance of the company's quality systems. Follows domestic and international regulatory standards (e.g., GMP and ISO 13485).

In This Role You Will

• Work closely with the Manufacturing and Design teams to design, develop, document, qualify/validate, and sustain manufacturing and test processes and equipment used during the manufacturing of electro-mechanical components and subassemblies of medical robotic systems.
• Create assessments to drive decisions that influence NPI and manufacturing strategies and processes that progress the product development process and product development lifecycle
• Author, execute, and present technical engineering protocols and reports and data, including (but not limited to) process characterization, process validation (IQ/OQ/PQ), and test method validation (TMV) activities
• Apply comprehensive & diverse knowledge of engineering principles to identify, analyze, and implement solutions for process development and continuous improvement projects towards critical metrics for Supply Chain and Operations
• Conduct root cause analyses to address manufacturing defects and non-conformances

Qualifications

Qualifications:

Education:

• A minimum of a Bachelor of Science Degree in a technical field (for example, Mechanical Engineering, Electrical Engineering, Biomedical Engineering, Robotics, Mathematics, etc.) is required.

Experience and Skills:

Required:

• A minimum of 4 plus years of experience in a technical field
• Ability to demonstrate proficiency and familiarity in electromechanical systems (i.e. demonstrate proficiency in the root cause analyses of electromechanical issues)
• Experience with process development activities such as (but not limited to) process characterizations, DOEs, equipment/fixturing/tooling and process design, etc.
• Experience with Process Validation (IQ/OQ/PQ), SW Validations, and/or Test Method Validations (TMV), and able to generate protocols and test reports
• Experience with conducting Product Risk Assessment and Product Risk Analyses (FMEA)
• Ability to read engineering drawings and schematics is required
• Proficiency and knowledge with electrical test equipment such as multimeters, oscilloscopes, and power supplies is required
• Ability to author and release Engineering Change Orders (ECOs) and manufacturing documentation (MPI, FAB, WI, DHR, etc.)

Preferred:

• Experience in Medical Device Quality Management Systems and industry GMPs and standards (e.g. 21 CFR Part 820, ISO 13485)
• Proficiency in statistical techniques, statistical process controls (SPC)
• Produce high quality documentation that is clearly understandable by internal and external personnel
• Experience in Product Lifecycle Management systems such as Oracle Agile is highly preferred
• Experience working on instrumentation automation and using scripting languages such as Python, Shell, Batch, Bash or Linux commands is preferred.
• Knowledge of LEAN/Six Sigma and Process Six Sigma is preferred.
• Ability to demonstrate familiarity in Statistical Process Controls (SPC)
• Familiarity with manufacturing and production systems such as ERP, MES, PLM, etc

Other:

• Ability to travel up to 10% to contract manufacturers is required

California Bay Area - The anticipated base pay range for this position is $89,000 to $140,185.

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)).
• This position is eligible to participate in the Company's long-term incentive program.
• 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

The compensation and benefits information set forth in this posting applies to candidates hired in the United States. Candidates hired outside the United States will be eligible for compensation and benefits in accordance with their local market."

This job posting is anticipated to close on Sept 4, 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.

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.

For more than 130 years, diversity, equity & inclusion (DEI) has been a part of our cultural fabric at Johnson & Johnson and woven into how we do business every day. Rooted in Our Credo, the values of DEI fuel our pursuit to create a healthier, more equitable world. Our diverse workforce and culture of belonging accelerate innovation to solve the world's most pressing healthcare challenges.

We know that the success of our business - and our ability to deliver meaningful solutions - depends on how well we understand and meet the diverse needs of the communities we serve. Which is why we foster a culture of inclusion and belonging where all perspectives, abilities and experiences are valued and our people can reach their potential.

At Johnson & Johnson, we all belong.