NPI​/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 Med Tech, 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.

Supply Chain Engineering

Manufacturing Engineering

Scientific/Technology

Santa Clara, California, United States of America

We are searching for the best talent for a Manufacturing Engineer, NPI in Santa Clara, CA. 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, dispensing, and/or packaging components and/or products.

Supports investigations to determine root cause of failures, presents results, and proposes corrective and preventive 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 R&D, Product Quality, Regulatory, and Supplier Quality. Provides 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).

• Work closely with the Manufacturing and Design teams to develop, document, qualify/validate, and sustain manufacturing and test processes and equipment used during the manufacturing of electro‑mechanical components and sub‑assemblies of medical robotic systems.
• Create assessments to drive decisions that influence NPI and manufacturing strategies and processes that progress the product development lifecycle.
• Author, execute, and present technical engineering protocols and reports and data, including process characterization, process validation (IQ/OQ/PQ), and test method validation (TMV) activities.
• Apply comprehensive and diverse knowledge of engineering principles to identify, analyze, and implement solutions for process development and continuous improvement projects toward critical metrics for Supply Chain and Operations.
• Conduct root‑cause analyses to address manufacturing defects and non‑conformances.

• Minimum of a Bachelor of Science degree in a technical field (e.g., Mechanical Engineering, Industrial Engineering, Electrical Engineering, Biomedical Engineering, Robotics, Mathematics).

• Minimum two years of relevant work experience.
• Proficiency in electromechanical systems and root‑cause analyses of electromechanical issues.
• Experience with process development activities such as process characterizations, DOEs, equipment/fixturing/tooling and process design.
• Experience with Process Validation (IQ/OQ/PQ), SW Validations, and/or Test Method Validations (TMV) and ability to generate protocols and test reports.
• Experience with conducting Product Risk Assessment and Product Risk Analyses (FMEA).
• Ability to read engineering drawings and schematics.
• Proficiency with electrical test equipment such as multimeters, oscilloscopes, and power supplies.
• Ability to author and release Engineering Change Orders (ECOs) and manufacturing documentation (MPI, FAB, WI, DHR, etc.).

• Experience in Medical Device Quality Management Systems and industry GMPs and standards (e.g., 21 CFR Part 820, ISO 13485).
• Proficiency in statistical techniques and statistical process controls (SPC).
• Produce high‑quality documentation that is clearly understandable by…