Staff NPI Engineer

at  Johnson Johnson

Robotics & Digital Solutions , part of the Johnson & Johnson family of companies, is recruiting for a NPI Staff 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/.

The Staff 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 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 Staff Mfg Eng, NPI will Lead Manufacturing and Process development activities across the organization and functional groups with responsibilities in the areas focus areas:

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 10+ years of relevant work experience in regulated industries such as aerospace, aircraft, or automotive, preferably medical device

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:

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.

Please refer the Job description for details