External Manufacturing Technical Lead

Johnson & Johnson•San Jose, CA

20h

About The Position

Johnson & Johnson's Family of Companies is recruiting for an External Manufacturing Technical Lead , within our Robotics and Digital (RAD) Solutions organization, supporting Flexible Robotics (MONARCH®)! 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 At Johnson & Johnson Robotics and Digital Solutions, we’re changing the trajectory of health for humanity, using robotics to enhance healthcare providers’ abilities and improve patients’ diagnoses, treatments, and recovery times. Johnson & Johnson Robotics was established in 2020 with the integration of Auris Health, Verb Surgical, C-SATS, and Ethicon. It comprises three key med-tech platforms: Flexible Robotics (MONARCH®), Surgical Robotics (OTTAVA™), and Digital Solutions. Join our collaborative, rapidly growing teams in the San Francisco Bay Area (Santa Clara), Cincinnati, and Seattle. You’ll collaborate on breakthrough medical technologies that unite multiple subject areas to build a connected digital ecosystem that advances medical professionals’ skills and improves patient outcomes. Position Overview: 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.

Requirements

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.
Ability to travel up to 20%, international and domestic

Nice To Haves

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 process engineering tools such as DOE’s, Statistical Methods, CAD (Solid-works/Pro-E/AutoCAD), GD&T, Process Simulation, Failure Analysis Techniques (Fault tree, Fish Bone Diagram).

Responsibilities

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 minimizing 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.

Benefits

employees are eligible to participate in the Company’s consolidated retirement plan (pension) and savings plan (401(k)).
This position is eligible to participate in the Company’s long-term incentive program.
Vacation –120 hours per calendar year
Sick time - 40 hours per calendar year; for employees who reside in the State of Colorado –48 hours per calendar year; for employees who reside in the State of Washington –56 hours per calendar year
Holiday pay, including Floating Holidays –13 days per calendar year
Work, Personal and Family Time - up to 40 hours per calendar year
Parental Leave – 480 hours within one year of the birth/adoption/foster care of a child
Bereavement Leave – 240 hours for an immediate family member: 40 hours for an extended family member per calendar year
Caregiver Leave – 80 hours in a 52-week rolling period
Volunteer Leave – 32 hours per calendar year
Military Spouse Time-Off – 80 hours per calendar year