Manufacturing Engineer

Johnson & Johnson • Santa Clara, CA

4d • Hybrid

About The Position

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).

Requirements

• 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.
• 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.).

Nice To Haves

• 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.

Responsibilities

• 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.

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 period
• Volunteer Leave – 32 hours per calendar year
• Military Spouse Time-Off – 80 hours per calendar year
• Consolidated retirement plan (pension)
• Savings plan (401(k))

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level