External Manufacturing Technical Lead

At Johnson & J Company, 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 Med Tech, 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.

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Supply Chain Engineering

Process Engineering

Scientific/Technology

Cincinnati, Ohio, United States of America, San Jose, California, United States of America

Johnson & J d Company’s Family of Companies is recruiting for an External Manufacturing Technical Lead
, within our Robotics and Digital (RAD) Solutions organization, supporting Flexible Robotics (MONARCH®)!

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

The External Manufacturing Technical Leads at JnJ are dedicated, adaptable and well‑versed in overall product development activities. They work closely with R&D, Quality, Manufacturing, Program Management, Supply Chain, Marketing, and Regulatory in coordinating all aspects of Process Development, Optimization, Validation, and Improvement throughout its lifecycle. Their greatest forte is influencing key engineering decisions with the right data resulting in a highly scalable and manufacturable product on day one of commercial launch.

They are also adept at making trade‑off decisions on product performance, design, process capability and final manufacturing outputs.

• Manage key relationships with external manufacturers, acting as the main technical liaison for communications and operational performance.
• Lead cross‑functional end‑to‑end process solution deployment, from feasibility to verification/validation for Instrument Manufacturing & Assembly processes (catheter and other devices), including, but not limited to lamination, braiding, tipping, soldering, final inspection, pouching/boxing/label printing, reprocessing and sterilization processes.
• Document and execute equipment/process validation protocols & reports.
• Drive continuous improvement with multiple external manufacturers to enhance product line performance and reliability.
• Serve as a point of escalation for issues, facilitate timely resolution and minimize operational disruptions.
• Lead mitigations to resolve root cause, provide recommendations and may lead NCR’s and CAPAs depending on the need or root cause.
• Provide strategic project oversight to support long‑range planning and capacity to meet future demand requirements.
• Perform analysis of investments requirements to support recurring cost reductions and business growth.

• A minimum of a Bachelors degree in an Engineering discipline.
• 8+ years professional experience outside of degree program.
• Knowledge of good manufacturing practices and documentation.
• Excellent written and oral communication skills.
• Experience in a regulated industry; medical device experience is a plus.
• Knowledge of computer programs in addition to Microsoft office products.
• Self‑starter with a desire to engage in proactive learning.
• Must be highly organized with the ability to drive projects/tasks simultaneously and effectively prioritize projects and tasks.
• Experience in process/product validations.

• A degree in Mechanical, Biomedical, or Industrial Engineering
• Six Sigma/Lean certification and practical experience
• Background in various catheter manufacturing related processes such as Braiding, Lamination, Soldering, Adhesive Bonding, Tipping, etc.
• Experience with commercial or pilot manufacturing lines & technical report writing.
• Familiarized with manufacturing processes equipment, such as ultrasonic welders, leak testers, pouch sealers, etc.
• Knowledge of a combination of…