Manufacturing New Product Introduction (NPI) Engineer

Auris Health

Auris Health

Santa Clara, CA, USA
Posted on Tuesday, September 12, 2023


The Robotic And Digital Solutions group, part of the Ethicon Medical Devices sector within Johnson & Johnson, is recruiting for a Manufacturing New Product Introduction (NPI) Engineer located in Santa Clara, CA .

Johnson & Johnson Medical Devices is focused on shaping the future of digital surgery and expanding its robotics and digital solutions offerings across the entire portfolio, with multi-specialty, end-to-end solutions in orthopedics, endoluminal intervention, and general surgery. This includes the MONARCH® platform, a first-of-its-kind robotic technology indicated for bronchoscopic visualization of and access to patient airways for diagnostic and therapeutic procedures in the lung.

Ethicon, part of Johnson & Johnson Medical Devices Companies, has made significant contributions to surgery for more than 100 years from creating the first sutures to revolutionizing surgery with minimally invasive procedures. Our continuing dedication to Shaping the Future of Surgery is built on our commitment to help address the world's most pressing healthcare issues and improve and save more lives. Through Ethicon's surgical technologies and solutions including sutures, staplers, energy devices, trocars and hemostats, and our commitment to treating serious medical conditions like obesity worldwide, we deliver innovation to make a life-changing impact. For more information, visit www.ethicon.com .

The Manufacturing NPI Engineer is responsible for acting as a team member on process development projects conducting various assignments in cooperation with direction of team & team leader. Scope of responsibility included specifying, procuring, qualifying, validating, troubleshooting, and maintaining equipment and process needed for robotic assembly, dispensing, and/or packaging components and/or products. Developing components and assemblies for processing. 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).


  • Works under general supervision.
  • Develop components, boards, and assemblies using DFx, GD&T, etc
  • Develop process windows/limits for manual and automated production processes.
  • Perform process validations as required, IQ/OQ/PQ; generate protocols and test reports.
  • Act as technical liaison between R&D Engineering and Manufacturing.
  • Complete engineering assignments involving design, development, testing.
  • Learns and maintains methods for inspecting, testing, and evaluating complaint-related product.
  • Design, develop, and improve manufacturing processes, equipment, and tooling.
  • Understands and applies test methods to locate, reproduce, identify, and analyze complex failures. Develop Process Failure Mode and Effects Analyses.
  • Apply comprehensive & and diverse knowledge of engineering principles to assignments.
  • Coordinate activities with internal & and external customers and suppliers.
  • Authors and reviews technical protocols, reports, standards and change orders.
  • Participates in the presentation of progress and results to all levels of organization.
  • Generates monthly status reports on individual activity.



Education: A minimum of a Bachelor of Science Degree in a technical field (for example, Electrical Engineering, Mathematics, Statistics, Mechanical Engineering, Industrial Engineering, Chemical Engineering, etc.)

Experience and Skills:


  • A minimum of 2-4 years of experience in a technical field is required
  • Experience with Process Validation (IQ/OQ/PQ), and the ability to generate protocols and test reports
  • Understanding of Risk Management (Medical Device)
  • Demonstrated ability to work effectively with cross-functional teams for qualifications, verifications, validations, complaint investigation, root cause analysis, identification, and implementation of CAPAs
  • Excellent communication skills, both verbal and written, and the ability to effectively interface within cross-functional teams


  • Experience with CAD, Geometric Dimensioning and Tolerancing (GD&T), board design
  • Knowledge of LEAN/ Six Sigma and Process Six Sigma
  • Understanding of Statistical Analysis used to identify issues in post-market surveillance, complaints, and servicing
  • Strong integration skills to identify Manufacturing and supplier-related issues of Medical Device Capital Equipment
  • The ability to multi-task with an established track record of meeting milestone schedules
  • Understands Failure Modes and Effects Analysis and Fault Tree Analysis
  • Prior experience or training in Manufacturing Engineering
  • Experience working in an ISO13485, GMP, or FDA-regulated environment


  • This role may require up to 10% of domestic and/or international travel
  • The anticipated base pay range for this position is $81,000-112,700/yr.

The Company maintains highly competitive, performance-based compensation programs. Under current guidelines, this position is eligible for an annual performance bonus in accordance with the terms of the applicable plan. The annual performance bonus is a cash bonus intended to provide an incentive to achieve annual targeted results by rewarding for individual and the corporation’s performance over a calendar/ performance year. Bonuses are awarded at the Company’s discretion on an individual basis.

Employees may be eligible to participate in Company employee benefit programs such as health insurance, savings plan, pension plan, disability plan, vacation pay, sick time, holiday pay, and work, personal and family time off in accordance with the terms of the applicable plans. For additional general information on company benefits, please go to: https://www.careers.jnj.com/employee-benefits

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.

At Johnson & Johnson, we’re on a mission to change the trajectory of health for humanity. That starts by creating the world’s healthiest workforce. Through cutting-edge programs and policies, we empower the physical, mental, emotional and financial health of our employees and the ones they love.

Johnson & Johnson is an Affirmative Action and 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, or protected veteran status and will not be discriminated against on the basis of disability.

For more information on how we support the whole health of our employees throughout their wellness, career and life journey, please visit www.careers.jnj.com .