Technical Operations Engineer II

7597-Ethicon LLC Legal Entity; San Lorenzo (PR); On-site; USD 70,000 - 95,000; Full time

Job summary

Johnson & Johnson MedTech in San Lorenzo, Puerto Rico, seeks a Technical Operations Engineer II to drive manufacturing process innovation, validation, and implementation. You will apply data-driven methods to improve quality, efficiency, and regulatory compliance, partnering with multiple functions across the site.

Required: BS in engineering, Lean Six Sigma basics, strong communication, and willingness to travel up to 10%.

Qualifications

• 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.
• Lean manufacturing tools experience and problem-solving.
• Six Sigma Green Belt or Black Belt preferred.
• Knowledge of GMPs and QSRs.
• Experience with Project management tools.

Responsibilities

• Lead qualification, validation, and implementation of new/updated processes, equipment, and products.
• Drive process optimization and continuous improvement using Lean Six Sigma and data methods.
• Provide day-to-day technical support for manufacturing operations to boost reliability and quality.
• Design, run, and analyze experiments using DOE and statistics.
• Monitor and improve OEE, downtime, yield, and process capability.
• Collaborate with manufacturing, quality, and cross-functional teams on process control systems.
• Manage projects and capital investments delivering on time, cost, and safety goals.
• Prepare validation protocols, reports, and change control packages.
• Support design transfer, scale-up, and commercialization of processes.

Skills

BS Degree or Equivalent

MS Degree

Computer skills

Verbal & written communication

Lean Six Sigma

Project management

Minitab knowledge

Education

BS Degree or Equivalent

Engineering degree (BSME/BSChE/BS EE)

Tools

Microsoft Project

Minitab

Microsoft Office

Job description

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 jnj.com. As guided by Our Credo, Johnson & Johnson is responsible to our employees who work with us throughout the world. We provide an inclusive work environment where each person is considered as an individual. At Johnson & Johnson we respect the diversity and dignity of our employees and recognize their merit.

Job Function: Supply Chain Engineering
Job Sub Function: Process Engineering
Job Category: Scientific/Technology
All Job Posting Locations: San Lorenzo, Puerto Rico, United States of America

Job Description

Johnson & Johnson MedTech s recruiting for an Technical Operations Engineer II located in San Lorenzo, Puerto Rico! An internal pre-identified candidate for consideration has been identified. However, all applications will be considered. Drive innovation and operational excellence by developing, optimizing, and validating manufacturing processes, systems, and equipment. Leverage advanced engineering tools and data-driven methodologies to improve quality, efficiency, and performance while ensuring compliance with regulatory, safety, and environmental standards. Partner cross-functionally to implement new technologies, troubleshoot complex manufacturing challenges, and support the successful launch of new products and processes.

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

About Surgery

Fueled by innovation at the intersection of biology and technology, we’re developing the next generation of smarter, less invasive, more personalized treatments. Are you passionate about improving and expanding the possibilities of surgery? Ready to join a team that’s reimagining how we heal? Our Surgery team will give you the chance to deliver surgical technologies and solutions to surgeons and healthcare professionals around the world. Your contributions will help effectively treat some of the world’s most prevalent conditions such as obesity, cardiovascular disease and cancer. Patients are waiting. Your unique talents will help patients on your journey to wellness. Learn more at https://www.jnj.com/medtech

Key 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.

Qualifications

Education

• Bachelor Science (BS) Degree or Equivalents
• Bachelor’s degree in Engineering Discipline; BSME, BSChE, BSEE, preferred or equivalents

Experience and Skills

Required

• 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.
• Prefer Six Sigma Green Belt or Black Belt certification or equivalent.
• 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.
• Prefer knowledge of lean manufacturing and manufacturing processes.
• 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.
• Preferred: 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.

Preferred Skills

• Analytical Reasoning, Computerized Equipment Skills, Corrective and Preventive Action (CAPA), Emerging Technologies, Execution Focus, Gemba Kaizen, Issue Escalation, Lean Supply Chain Management, Process Control, Process Engineering, Process Oriented, Product Improvements, Project Engineering, Safety-Oriented, Science, Technology, Engineering, and Math (STEM) Application, Situational Awareness, Technical Research, Technologically Savvy

English Fluency is required

10% Travel

Equal Opportunity Employer

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 & 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, external applicants please contact us via https://www.jnj.com/contact-us/careers, internal employees contact AskGS to be directed to your accommodation resource.

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/.

Do Not Sell or Share My Personal Information Limit the Use of My Personal Information