Senior NPI Manufacturing Engineer - Johnson and Johnson

Johnson & Johnson's Medical Devices Family of Companies, is currently recruiting for a Senior NPI Manufacturing Engineer, located in Santa Clara, CA

At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through 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 humanity. Learn more at https://www.jnj.com/ (https://www.jnj.com/).

Key Role Responsibilities

• High drive and urgency to launch quality products to market

• High drive to innovate through continuous improvement throughout the product's 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 NPI Manufacturing Engineer 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 Mfg Eng, 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 CM's

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 Education Requirements:

A minimum of a Bachelor's 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. Master's or advanced degree preferred.

• Minimum of 6-8 years of relevant work experience in regulated industries such as aerospace, aircraft, or automotive, preferably medical device

Required Skills:

• 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:

o 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:

o Manufacturing equipment design and development

o Process validation planning/execution, IQ/OQ/PQ protocols and reports

o Regulated industries component and manufacturing qualification processes

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

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

o Risk-based manufacturing documentation, including process and component FMEAs

o Crafting machine qualification requirements, design of experiments and failure analysis

o COGS Analysis

o 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 Skills:

• Experience with robotics or large capital equipment assembly

• Strong understanding of robotic systems encompassing hardware, software, and firmware components

o 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:

• This position may require up to 10% of travel both internationally and domestically.

• The anticipated base pay range for this position is 91,000 to 14,7200. California Bay Area - The anticipated base pay range for this position is 105,000 to 16,9050

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