Manufacturing Engineer

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 jnj.com

As guided by Our Credo, Johnson & Johnson is responsible to our employees who work with us throughout the world.  We provide an inclusive work environment where each person is considered as an individual.  At Johnson & Johnson, we respect the diversity and dignity of our employees and recognize their merit.

Job Function:

Supply Chain Engineering

Job Sub Function:

Manufacturing Engineering

Job Category:

Scientific/Technology

All Job Posting Locations:

Santa Clara, California, United States of America

Job Description:

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

About MedTech
Fueled by innovation at the intersection of biology and technology, we’re developing the next generation of smarter, less
invasive, more personalized treatments.
 

Your unique talents will help patients on their journey to wellness. Learn more at https://www.jnj.com/medtech

Purpose:

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 includes:

• Specifying, procuring, qualifying, validating, troubleshooting, and maintaining process and test equipment and manufacturing and test procedures needed for robotic assembly and test
• Supporting investigations to determine root cause of failures, presenting results, and proposing corrective and preventative actions as required
• Using capabilities, such as Lean/Six Sigma, DFx, SPC, etc, to improve company knowledge, products and processes
• Collaborating and interacting with other company engineering teams, including R&D, Product Quality, Regulatory, and Supplier Quality
• Providing engineering, risk assessment, and statistics support in the development and maintenance of the company’s quality systems
• Following 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:

Education:

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

Experience and Skills:Required:

• 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 15% to manufacturing sites is required

Required Skills:

Preferred Skills:

Accelerating, Analytical Reasoning, Coaching, Communication, Facility Management, Good Manufacturing Practices (GMP), Lean Manufacturing Principles, Lean Supply Chain Management, Manufacturing Engineering, Manufacturing Science and Technology (MSAT), Problem Management, Project Engineering, Project Schedule, Report Writing, Safety-Oriented, Science, Technology, Engineering, and Math (STEM) Application, Technologically Savvy

The anticipated base pay range for this position is :

$91,000.00 - $147,200.00

Additional Description for Pay Transparency:

Subject to the terms of their respective plans, employees are eligible to participate in the Company’s consolidated retirement plan (pension) and savings plan (401(k)).
Subject to the terms of their respective policies and date of hire, employees are eligible for the following time off benefits:
Vacation –120 hours per calendar year
Sick time - 40 hours per calendar year; for employees who reside in the State of Colorado –48 hours per calendar year; for employees who reside in the State of Washington –56 hours per calendar year
Holiday pay, including Floating Holidays –13 days per calendar year
Work, Personal and Family Time - up to 40 hours per calendar year
Parental Leave – 480 hours within one year of the birth/adoption/foster care of a child
Bereavement Leave – 240 hours for an immediate family member: 40 hours for an extended family member per calendar year
Caregiver Leave – 80 hours in a 52-week rolling period10 days
Volunteer Leave – 32 hours per calendar year
Military Spouse Time-Off – 80 hours per calendar year
For additional general information on Company benefits, please go to: - https://www.careers.jnj.com/employee-benefits