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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

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:

We are searching for the best talent for a Manufacturing Engineer, NPI 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 outstanding talents will help patients on their journey to wellness. Learn more at https://www.jnj.com/medtech

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:

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:

+ minimum two years of relevant work experience

+ 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

+ This position is fully onsite Monday- Friday

Johnson & Johnson is an 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, disability, protected veteran status or other characteristics protected by federal, state or local law.

We actively seek qualified candidates who are protected veterans and individuals with disabilities as defined under VEVRAA and Section 503 of the Rehabilitation Act.

Johnson and Johnson is committed to providing an interview process that is inclusive of our applicants’ needs. If you are an individual with a disability and would like to request an accommodation, please email the Employee Health Support Center ( [email protected] ) or contact AskGS to be directed to your accommodation resource.

The anticipated base pay range for this position is :

$89,000- $142,600

Additional Description for Pay Transparency:

Subject to the terms of their respective plans, employees and/or eligible dependents are 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. 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)). This position is eligible to participate in the Company’s long-term incentive program. 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 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 Condolence Leave – 30 days for an immediate family member: 5 days for an extended family member Caregiver Leave – 10 days Volunteer Leave – 4 days Military Spouse Time-Off – 80 hours Additional information can be found through the link below. https://www.careers.jnj.com/employee-benefits Co-Ops and Intern Positions: Co-Ops/Interns are eligible to participate in Company sponsored employee medical benefits in accordance with the terms of the plan. Co-Ops and Interns are eligible for the following sick time benefits: up to 40 hours per calendar year; for employees who reside in the State of Washington, up to 56 hours per calendar year Co-Ops and Interns are eligible to participate in the Company’s consolidated retirement plan (pension) Positions Represented by CBA: This position is 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. 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.