Technical Operations Engineer II

Johnson & Johnson•San Lorenzo, PR

4d•Onsite

About The Position

Johnson & Johnson MedTech is recruiting for an Technical Operations Engineer II located in San Lorenzo, Puerto Rico! This role focuses on driving innovation and operational excellence by developing, optimizing, and validating manufacturing processes, systems, and equipment. The engineer will leverage advanced engineering tools and data-driven methodologies to improve quality, efficiency, and performance while ensuring compliance with regulatory, safety, and environmental standards. Collaboration with cross-functional teams is key for implementing new technologies, troubleshooting complex manufacturing challenges, and supporting new product and process launches. The role is within the Surgery team, which develops next-generation smarter, less invasive, and more personalized treatments, contributing to the effective treatment of prevalent conditions.

Requirements

Bachelor Science (BS) Degree or Equivalents
Bachelor’s degree in Engineering Discipline; BSME, BSChE, BSEE, preferred or equivalents Bachelor’s Degree.
BS Degree or Equivalent with 2-4 years or more related experience.
MS Degree with 1-year experience.
Computer and database management skills.
Excellent verbal and written communication skills.
Excellence communication and interpersonal relation skills.
Desire practical, first-hand experience successfully applying lean manufacturing tools with documented improvement project completion.
Statistical and analytical problem sol.
Knowledge of 21CFR 820, 21 CFR 4 and ISO 13485/EN ISO 13485.
Knowledge of Statistical and analytical problem-solving methodologies.
Knowledge of SPC, DOE, computer skills (word processing, database, graphical data presentation).
Knowledge of Good Manufacturing Practices (GMPs) and Quality System Regulations (QSRs).
Knowledge of Microsoft Office (Word, Excel, PowerPoint, and Outlook) is required.
Ability to initiate and manage change as well as build effective teams across manufacturing and support
English Fluency is required

Nice To Haves

Prefer Six Sigma Green Belt or Black Belt certification or equivalent.
Prefer knowledge of lean manufacturing and manufacturing processes.
Current Certified Engineer, preferred.
Training in Process Excellence/Six Sigma tools and methodologies and Certification preferred.
Experience with Microsoft Project is preferred.
Experience with Minitab is preferred.
Experience in leading and managing projects and milestones preferred.

Responsibilities

Lead the qualification, validation, and implementation of new and enhanced manufacturing processes, equipment, and products.
Drive process optimization and continuous improvement initiatives using Lean Six Sigma, Process Excellence, and data-driven methodologies.
Provide day-to-day technical support and troubleshooting for manufacturing operations to improve reliability, quality, and productivity.
Design, execute, and analyze experiments using statistical tools and Design of Experiments (DOE) to solve complex manufacturing challenges.
Develop, monitor, and improve operational performance metrics, including OEE, downtime, yield, and process capability.
Partner with manufacturing, quality, and cross-functional teams to develop, install, and sustain robust process control systems.
Manage engineering projects and capital investments, ensuring delivery against quality, cost, safety, and timeline objectives.
Prepare and maintain technical documentation, including validation protocols, reports, strategies, and change control packages.
Support the design, transfer, scale-up, and commercialization of manufacturing processes and technologies.
Ensure compliance with all regulatory, quality, environmental, health, and safety requirements while fostering a culture of collaboration and continuous improvement.