Senior Test Manufacturing Engineer, NPI

Full Time
Santa Clara, CA
Posted
Job description

Robotics & Digital Solutions, part of the Johnson & Johnson family of companies, is recruiting for a Senior Test Manufacturing Engineer, NPI located in Santa Clara, CA.

Robotics & Digital Solutions is part of Ethicon, Inc., a global leader in surgery with products and solutions found in almost every operating room around the world. Ethicon 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 Shape the Future of Surgery is built on our commitment to help address the world's most pressing health care issues and improve and save more lives. Through Ethicon's surgical technologies and solutions including robotics, digital solutions, sutures, staplers, energy devices, trocars and hemostats and our commitment to treat serious medical conditions like obesity and cancer worldwide, we deliver innovation to make a life-changing impact. For more information, visit www.ethicon.com.

The Senior Test Manufacturing Engineer, NPI is an individual with high drive and urgency to launch products to market. This individual has a passion to make a quality product and innovate through continuous improvement throughout the product’s life cycle. In this role, this individual is highly collaborative and works with R&D teams, Technicians, and peers to develop the manufacturing process for medical robotic systems. This individual is also capable and excited about developing, documenting and qualifying test processes used during the manufacturing of electro-mechanical components and subassemblies. This individual is continuously providing feedback on Design For Manufacturability and Assembly, challenging the status quo while understanding the “why” in design intent and overall product functionality.

Job Responsibilities:

  • Collaborate, coach and support design teams to develop and introduce manufacturing processes that scale to commercialization.
  • Design, develop, document, and qualify electro-mechanical manufacturing fixtures utilizing both custom and off-the shelf hardware and software
  • Assist in the development of test algorithms, test scripts, data acquisition and measurement systems with focus on repeatability and reproducibility
  • Automate test processes utilizing in-house developed test software and scripts
  • Release engineering documentation and bill of materials
  • Work under general guidance to contribute to all aspects of test development, coverage, drive execution and test results documentation
  • Lead projects with a high sense of urgency and quality; does not wait to do what is right
  • Lead troubleshooting investigations and resolve manufacturing production issues following GMP and the companies Quality Management System.
  • Act as technical lead and participate in daily stand-up meetings to support build schedule and activities
  • Lead Corrective and Preventative Action plans by providing solutions using independent thinking and problem-solving skills including Root Cause Identification, Fishbone, 5 Whys, or Pareto Charts.
  • Plan, define and implement continuous process improvements to existing manufacturing operations including process verification, MFG documentation updates and process validation.
  • Design, document, assemble, qualify, and release custom and off the shelf manufacturing and testing tooling, fixtures, and equipment.
  • Collaborate and develop Test Processes along side peers and cross-functional teams.
  • Create and release associated maintenance and calibration procedures.
  • Perform routine equipment preventative maintenance and/or repair and serve as manufacturing liaison for external calibration activities.
  • Author and execute manufacturing documentation, including protocols, reports, manufacturing process instructions, standard operating procedures, and equipment/fixture specifications.
  • Generate production metrics including yields, scrap rates, capacity/bottle necks and cycle times and routinely present to management.
  • Other manufacturing engineering duties or support as assigned or requested.

This role requires the use of varying levels of personal protective equipment (including, gowns, masks/face shields, gloves, and safety glasses). This role routinely uses standard office equipment such as computers, phones, and photocopiers. Must be able to lift a minimum of 25 pounds and perform repetitive bending and lifting motions over a period of time. While performing the duties of this job, the employee is regularly required to talk or hear. The employee frequently is required to stand, walk; use hands to finger, handle or feel; and reach with hands and arms.

Qualifications

  • Bachelor's degree in Electrical Engineering, Mechanical Engineer or related engineering field is required. Mechatronics Engineering degree preferred. Master’s or advanced degree preferred.
  • Minimum of 6-8+ years relevant work experience with GMP/GDP
  • Produce high quality documentation that is clearly understandable by internal and external personnel is required
  • Basic understanding and experience of electrical systems and is required
  • 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
  • Experience in Product Lifecycle Management systems such as Oracle Agile is highly preferred
  • Experience in Medical Device industry, Robotics, Manufacturing, and MES is preferred
  • Experience working on instrumentation automation and using scripting languages such as Python, Shell, Batch, Bash or Linux commands is highly preferred
  • Experience with process validation planning/execution, IQ/OQ/PQ protocols and reports.
  • Understanding of statistical methods

Other:

  • Ability to travel (10%) to and from headquarters in Santa Clara, CA
  • The anticipated base pay range for this position is $116,000 to $187,795.

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. As such, candidates offered employment must show proof of COVID-19 vaccination or secure an approved accommodation prior to the commencement of employment to support the well-being of our employees, their families and the communities in which we live and work.

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

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