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

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About MedTech

Fueled by innovation at the intersection of biology and technology, we’re 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 https: //www.jnj.com/medtech

An internal pre-identified candidate for consideration has been identified. However, all applications will be considered.

We are searching for the best talent for Staff Quality Engineer Product Dev to be in Irvine, California.

Key Responsibilities:

• As part of New Product Development team, contribute to development activities, including design verification test, process validations, and quality processes.

• Serve as subject matter expert on quality lifecycle management and related Quality tools.

• Responsible for revision/approval of engineering drawings for both device components and Tool/Jig/equipment, correct application of GD& T, stack up analysis, etc.

• Develop and establish effective quality control and associated risk management plans.

• Support all Quality Engineering activities for the Life Cycle Management function, including Cost Improvement Projects (CIPs) and Component Qualification activities. Ensure compliance with the internal quality system policies and applicable external requirements and standards, including FDA, ISO 13485, CMDCAS, PMDA and other standards as applicable to medical devices.

• Contribute to quality and process activities for Reliability, Risk Management, Analytics/statistical techniques, Requirements Management, and Verification & Validation.

• Lead quality improvement efforts for legacy products, continuous improvement, and customer satisfaction. Design or redesign mechanical and thermal devices or subsystems, using computer-aided design, and develop and test prototypes.

• Write, review, and/or approve process and product validation protocols and reports, equipment qualifications, and engineering change orders.

• Use statistical tools to analyze data, make acceptance decisions, and improve process capability, with Six Sigma, Statistical Process Control (SPC), Design of Experiments (DOE), etc. Direct Failure Mode and Effects Analysis (FMEA) activities for both Design and Process risk assessments. Knowledge of plastics, mold design, and molding/extrusion processes that allows the quality team to proactively identify potential issues in material selection, component design (DFM), and process parameters that could cause defects such as warpage, imbalances in multi-cavity molds, flash, voids, warping, undercuts, burrs, dimensions out of specification. SME can then recommend corrective actions and preventative measures, reducing scrap rates and rework.

• Determine sterility, biological and packaging test requirements utilizing appropriate industry or agency standards for new products. Investigate equipment failures or difficulties to diagnose faulty operation and to recommend remedies.

• Participate in Material Review Board (MRB) review of nonconforming product, and recommend disposition and corrective action.

Qualifications:

Required:

• Bachelor's Degree in Engineering or equivalent related field

Preferred:

• Master's Degree

• 10 years of experience in related field, automative or medical industry

• Supporting global suppliers of tooling for purchased plastic parts by conducting thorough tool design reviews, review tool capability runs ensuring deployment of appropriate technology and design and analyzing performance data to align tooling performance with startup and long-term business requirements.

Additional Information:

This job posting is anticipated to close on 09/23 /25. The Company may however extend this time-period, in which case the posting will remain available on https: //www.careers.jnj.com to accept additional applications

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 (ra-employeehealthsup@its.jnj.com) or contact AskGS to be directed to your accommodation resource

The anticipated base pay range for this position is:

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