Senior Manufacturing Engineer (1 of 2 Openings)

Robotics & Digital Solutions, part of the Johnson & Johnson family of companies, is recruiting for a Senior Manufacturing Engineer. 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 Manufacturing Engineer is responsible for new product introduction and identifying and implementing continuous process improvements. The position will be responsible for on-demand production line support, define manufacturing driven metrics (cycle times, capacity, bottlenecks etc.), design, duplicate and/or deploy manufacturing fixture and tooling, develop and train on manufacturing processes and perform equipment qualification and process validation activities.Key Responsibilities:Provide daily support to troubleshoot and resolve manufacturing production issues following GMP and company Quality Management System

Identify root cause of operational failures and support Corrective and Preventative Action plans by provide solutions using problem-solving skills including Fishbone, 5 Whys or Pareto Charts

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. 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

QualificationsRequiredBachelor' Degree in Engineering: Manufacturing, Industrial, Mechanical, Biomedical or related field and 5 years experience as design or manufacturing engineer supporting product development or production lines

ORMaster’s Degree Engineering: Manufacturing, Industrial, Mechanical, Biomedical or related field and 3 years experience as design or manufacturing engineer supporting product development or production lines

Experience with GMP/GDP

Experience with manufacturing equipment design and development

Experience with process validation planning/execution, IQ/OQ/PQ protocols and reports

Understanding of statistical methods

SolidWorks Experience

Proficient with standard business software (MS Office, Excel, Outlook etc.)

Prior experience in medical device, working in regulated environment in compliance to ISO 13485 and 21 CFR 820

This is a full-time position - First shift days and hours of work are flexible

Occasional evening and weekend work may be required as job duties demand

Ability to travel (10%) to and from headquarters in Santa Clara, CA

PreferredAdvanced Degree

Agile PLM experience

CAMSTAR experience

Understanding of engineered materials and fabrication methods

Experience with robotics or large capital equipment assembly

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.Primary LocationUnited States-California-Santa Clara-5490 Great America PkwyOrganizationVerb Surgical Inc. (6270)Job FunctionEngineeringRequisition ID2105888205W