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

Remote Candidates will not be considered for this position.

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, 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 Assembly, COGS, Manufacturability, Quality, etc, challenging the status quo while understanding the “why” in design intent and overall product functionality.

The Sr Mfg Eng, NPI will Lead Development activities and support across the organization and functional groups focusing on several areas:

Key Role Responsibilities:

• Component and manufacturing assembly development with a strong focus on DFx methodologies (Design for Manufacturability/Assembly/Cost/Quality/x).

• Expectations are the successful transition from R&D to NPI Operations, to steady state manufacturing/commercial release.

• Strong leadership capabilities in this Development Role to manage and develop junior Mfg Eng, NPI team.

• Serves as a liaison with the suppliers of components/equipment between R&D, Supply Chain, and Operations.

• Collaborate, coach and support design teams to develop and introduce manufacturing processes that scale to commercialization.

• Lead projects with a high sense of urgency and quality

• Lead troubleshooting/root cause investigations and resolve manufacturing production issues following GMP and the companies Quality Management System.

• Leverages component and assembly development across the J&J network of SMEs, building a strong technical a network.

• Will own and/or manage the execution of the component development process including: Inspection Methodologies with suppliers and internal teams, Inspection Plan management, and Component Qualifications.

• Lead Corrective and Preventative Action plans by providing solutions using independent thinking and problem-solving skills including 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, off the shelf manufacturing and testing tooling, fixtures, and equipment, including maintenance and calibration.

• Collaborate and develop Manufacturing and Test Processes with cross-functional teams.

• 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

Education:

A minimum of a Bachelor's or equivalent University Degree is required with a primary focus in Manufacturing/Industrial, Mechanical, Electrical engineering, or related field is required, Mechatronics Engineering degree preferred. Master’s or advanced degree preferred.

• Minimum of 6-8+ years relevant work experience with GMP/GDP

• Ability to read engineering drawings and schematics is required

• Experience with manufacturing equipment design and development

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

• 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.

Required Skills:

• GD&T Methodologies

• DFx Methodologies

• Knowledge of a broad range of component manufacturing methods/processes (Metals/Plastics/Electro-Mechanical)

• Experience with regulated industries component and manufacturing qualification processes.

• Experience using Statistical Methods for Manufacturing Process Capability and Control

• Experience with Measurement System Analyses (MSA) and Gage R&R and Compatibility

• Experience with risk-based manufacturing documentation, including process and component supplier FMEAs.

• Supplier Selection Criteria

• COGS Analyses Experience

Preferred Skills:

• Agile PLM experience

• MES experience

• Six-Sigma and Lean Manufacturing Certification

• Experience with robotics or large capital equipment assembly.

• Experience working on instrumentation automation and using scripting languages such as Python, Shell, Batch, Bash or Linux commands is highly preferred

Other:

• Ability to travel (25%) to and from headquarters in Santa Clara, CA and/or Cincinnati, OH Johnson & Johnson sites. A minimum of 25% of the time will be required to be on-site at the Santa Clara Facility and flexible work hours revolve around core 9AM-3PM PST or applicable supplier time zone.

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