Sr NPI Manufacturing Engineer

At Johnson & Johnsonwe believe health is everything. Our strength in healthcare innovation empowers us to build aworld where complex diseases are prevented treated and curedwhere treatments are smarter and less invasive andsolutions are 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 more at

Job Function:

Job Sub Function:

Job Category:

All Job Posting Locations:

Job Description:

About MedTech

Fueled by innovation at the intersection of biology and technology were developing the next generation of smarter less invasive more personalized treatments.

Your unique talents will help patients on their journey to wellness. Learn more at are searching for the best talent for a Sr NPI Manufacturing Engineer to be in Santa Clara CA.

Purpose:

The Senior Manufacturing Engineer NPI is an individual with:

• High drive and urgency to launch quality products to market

• High drive to innovate through continuous improvement throughout the products life cycle.

• Highly collaborative; works with Supply Chain and R&D Teams Technicians Quality and peers to develop a world-class manufacturing process for Medical Robotic Capital Systems

• Strong determination ability and excitement leading and developing documenting and qualifying test processes used during the manufacturing of electro-mechanical components and subassemblies

• Experience in making process improvements that yield both a profitable and reliable product

• Clear communication when providing feedback on Design For Assembly COGS Manufacturability Quality etc

• A positive take on challenging the status quo to drive process excellence while understanding the why in design intent patient safety and overall product functionality

• Eagerness to engage in hands-on activities comprehending system interactions and automating repetitive tasks

• Aptitude for quickly formulating action plans and executing them effectively to address challenges

• Demonstrated resilience proactivity and a positive mindset when facing challenging circumstances

• Vision to develop and undertake projects that can handle the complexities in scaling up a robotic system in future advanced manufacturing methods

You will be responsible for:

Robotics & Digital Solutions part of the Johnson & Johnson family of companies is recruiting for a NPI Senior Manufacturing Engineer 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 worlds most pressing health care issues and improve and save more lives. Through Ethicons 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 .

The Senior Manufacturing Engineer NPI is an individual with:

• High drive and urgency to launch quality products to market

• High drive to innovate through continuous improvement throughout the products life cycle.

• Highly collaborative; works with Supply Chain and R&D Teams Technicians Quality and peers to develop a world-class manufacturing process for Medical Robotic Capital Systems

• Strong determination ability and excitement leading and developing documenting and qualifying test processes used during the manufacturing of electro-mechanical components and subassemblies

• Experience in making process improvements that yield both a profitable and reliable product

• Clear communication when providing feedback on Design For Assembly COGS Manufacturability Quality etc

• A positive take on challenging the status quo to drive process excellence while understanding the why in design intent patient safety and overall product functionality

• Eagerness to engage in hands-on activities comprehending system interactions and automating repetitive tasks

• Aptitude for quickly formulating action plans and executing them effectively to address challenges

• Demonstrated resilience proactivity and a positive mindset when facing challenging circumstances

• Vision to develop and undertake projects that can handle the complexities in scaling up a robotic system in future advanced manufacturing methods

The Senior Manufacturing Engineer NPI will Lead Manufacturing and Process development activities across the organization and functional groups with responsibilities in the areas focus areas:

General Engineering and Leadership

Strong leadership capabilities to mentor coach and develop various experience level Manufacturing Engineer NPI teams

Collaborates coaches and supports design teams to develop and introduce manufacturing processes that scale to commercialization.

Thoroughly documents procedures and results to ensure traceability and promote knowledge sharing among team members

Technical leader and driver on owned projects; serve as a technical resource to other engineering groups and project leaders

Process Engineering

Develops new and or improved processes through the application of theoretical and practical engineering

Designs and develops technically complex processes to improve quality and efficiency.

Utilizes statistical tools (such as GR&R SPC and Cp/Cpk) to ensure processes/fixtures are scalable and are continuing to perform properly once qualified

Analyses and evaluates all meaningful technical trends and developments and incorporates them in appropriate assignments

Responsible for data analysis reports to communicate machine capability to cross-functional teams

Plans defines and implements continuous process improvements to existing manufacturing operations including process verification MFG documentation updates and process validation

Designs documents assembles qualifies and releases custom off-the-shelf manufacturing and testing tooling fixtures and equipment including maintenance plans and calibrations.

Product Engineering

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

Provides early and ongoing manufacturing involvement to ensure new products are mechanically manufacturable

Capable in understanding and building Tolerance Analysis of parts and assemblies

Releases engineering documentation and Bill of Materials

Provides direction and mentorship to third party machine/automation suppliers and/or CMs

Failure/Data analysis and Troubleshooting

Develops Manufacturing and Test Processes with cross-functional teams

Leads Corrective and Preventative Action plans by providing solutions using independent thinking and problem-solving skills including FMEAS Fishbone 5 Whys or Pareto Charts.

Leads troubleshooting/root cause investigations and resolves manufacturing production issues following GMP and the companies Quality Management System.

Genuine curiosity to comprehend the functioning and troubleshooting of systems coupled with a proven ability to identify and resolve technical issues efficiently

Qualifications / Requirements:

Education Requirements:

A minimum of a Bachelors or equivalent University Degree is required with a primary focus in Mechanical Manufacturing/Industrial Electrical engineering or related field is required Mechatronics Engineering degree preferred. Masters or advanced degree preferred.

Experience Requirements:

Proficiency in reading engineering drawings and electrical schematics

Proficiency with GD&T Methodologies

Proficient in SolidWorks and PDM

Proficient in performing system/electrical debug using instrumentation such as:

oscilloscopes DMMs multi-meters other advanced test instruments

Capable of communicating complex technical problems to a wide audience of experience

Versed and experienced in Good Engineering Practices (GEP) and Good Manufacturing Practices (GMP).

Able to make models first principle calculations and simulations to solve technical problems

Strong understanding and experience executing on:

• Manufacturing equipment design and development

• Process validation planning/execution IQ/OQ/PQ protocols and reports

• Regulated industries component and manufacturing qualification processes

• Using Statistical Methods for Manufacturing Process Capability and Control (SPC and Cp/Cpk)

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

• Risk-based manufacturing documentation including process and component FMEAs

• Crafting machine qualification requirements design of experiments and failure analysis

• COGS Analysis

• DFx Methodologies

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

Understands machine qualification including calibration correlation capability repeatability and reproducibility

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

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

Preferred:

Experience with robotics or large capital equipment assembly

Strong understanding of robotic systems encompassing hardware software and firmware components

Familiarity with various sensors and their integration

Experience in automation equipment used for alignment assembly and/or measurement of components.

Conducts research and analysis to identify state-of-the-art technologies algorithms and equipment for testing robotic systems and subsystems

Creates customized test applications to enhance the efficiency modularity and repeatability of system validation processes

Agile PLM and MES experience

Experience with Composer SW

Experience working with JIRA and Scrum Project Management Methodology

Six-Sigma and Lean Manufacturing Certification

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 (10%) to and from headquarters in Santa Clara CA At Johnson & Johnson where were on a mission to change the trajectory of health for humanity. That starts by creating the worlds healthiest workforce.

Additional Information:

The anticipated base pay range for this position is $105000 to $169050.

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 corporations performance over a calendar/performance year. Bonuses are awarded at the Companys discretion on an individual basis.

• Employees and/or eligible dependents may be eligible to participate in the following Company sponsored employee benefit programs: medical dental vision life insurance short- and long-term disability business accident insurance and group legal insurance.

• Employees may be eligible to participate in the Companys consolidated retirement plan (pension) and savings plan (401(k)).

• This position is eligible to participate in the Companys long-term incentive program.

• Employees are eligible for the following time off benefits:

  • Vacation up to 120 hours per calendar year

  • Sick time - up to 40 hours per calendar year; for employees who reside in the State of Washington up to 56 hours per calendar year

  • Holiday pay including Floating Holidays up to 13 days per calendar year of Work Personal and Family Time - up to 40 hours per calendar year

• Additional information can be found through the link below. 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.

  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 corporations performance over a calendar/performance year. Bonuses are awarded at the Companys discretion on an individual basis.

  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 and 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 () or contact AskGS to be directed to your accommodation resource

  Required Skills:

  Preferred Skills:

  Accelerating Coaching Critical Thinking Facility Management Good Manufacturing Practices (GMP) Lean Manufacturing Principles Lean Supply Chain Management Manufacturing Engineering Performance Measurement Product Design Program Management Project Engineering Project Scheduling Risk Compliance Robotic Automation Safety-Oriented Science Technology Engineering and Math (STEM) Application Technologically Savvy

  The anticipated base pay range for this position is :

  The anticipated base pay range for this position is $105000 to $169050.

  Additional Description for Pay Transparency: