Johnson & Johnson is hiring: NPI/Manufacturing Engineer in Santa Clara
Johnson & Johnson, Santa Clara, CA, United States, 95053
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.
Job Function
Supply Chain Engineering
Job Sub Function
Manufacturing Engineering
Job Category
Scientific/Technology
Job Posting Location
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. 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).
In This Role You Will
- 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.
Qualifications
Education
- Minimum of a Bachelor of Science degree in a technical field (e.g., Mechanical Engineering, Industrial Engineering, Electrical Engineering, Biomedical Engineering, Robotics, Mathematics).
Experience and Skills – Required
- 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 and Skills – 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 and 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.
- Experience working on instrumentation automation and using scripting languages such as Python, Shell, Batch, Bash or Linux commands.
- Knowledge of LEAN/Six Sigma and Process Six Sigma.
- 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.
- 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 & 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 (ra-employeehealthsup@its.jnj.com) or contact AskGS to be directed to your accommodation resource.
Salary range: $89,000–$142,600.
Benefits include medical, dental, vision, life insurance, short‑ and long‑term disability, business accident insurance, group legal insurance, 401(k) retirement plan, long‑term incentive program, vacation, sick time, holiday pay (including floating holidays), work/personal/family time, parental leave, condolence leave, caregiver leave, volunteer leave, military spouse time‑off, and other benefits as detailed on our benefits page (https://www.careers.jnj.com/employee-benefits).