Manufacturing Engineer

At Johnson & Johnsonwe believe health is everything. Our strength in healthcare innovation empowers us to build aworld where complex diseases are prevented treated and curedwhere treatments are smarter and less invasive andsolutions are 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 more at

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.

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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 were 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 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 companys 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:

The anticipated base pay range for this position is :

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