Senior Manufacturing Engineer

Johnson & Johnson•Anasco, PR

29d

About The Position

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 on the possibilities of vision treatments? Ready to join a team that’s reimagining how vision is improved? Our Vision team solves the toughest health challenges. Help combine cutting-edge insights, science, technology, and people to encourage eye care professionals and patients to proactively protect, correct and enhance healthy sight for life. Our products and services address these needs – from the pediatric to aging eye – in a patient’s lifetime. Your unique talents will help patients on their journey to wellness. Learn more at https://www.jnj.com/medtech Under the direction of the Engineering Manager, handles most aspects of a project or initiative. Role is responsible for problem identification, reporting, root cause analysis, project management, financial analysis, efficiency or productivity improvement, reporting, and problem solving. Role interfaces directly with other department, sites, and corporate functional groups to drive and/or support critical business goals/ objectives within GMP/ISO compliance. Lead/ Support continuous improvement activities to ensure business key performance indicators are met. Lead groups of Engineers or Technicians on projects or special assignments. Creates and presents CAR for the Project responsible.

Requirements

Bachelor’s degree in Engineering is required
Minimum four (4) years of experience is required in a manufacturing, R&D or process development environment.
Strong expertise in Lean Manufacturing, Six Sigma, and other performance optimization methodologies.
Deep knowledge of medical device regulatory requirements (FDA QSR, ISO 13485, EU MDR).
Experience with process validation, automation, and risk management.
Proficiency with CAD, MES, ERP systems, and automation tools.
Excellent analytical, problem-solving, and team leadership skills.

Nice To Haves

Experience in Medical Device or Pharmaceutical industry is preferred
Six Sigma certifications or equivalent is preferred

Responsibilities

Leads and executes moderately to highly complex projects, ensuring safety, regulatory compliance, and business needs are met
Optimizes process output, equipment utilization, waste reduction, and cost management creatively.
Provides technical support for process deficiencies, changes, and equipment issues, analyzing and resolving problems promptly.
Sets engineering standards, mentors the team, and challenges the status quo to develop innovative process ideas.
Collaborates across site functions and divisions during project phases.
Supports non-conformance investigations, generating reports and corrective actions, and troubleshooting equipment to boost production and team capabilities.
Ensures adherence to BOPs, GMPs, company policies, and regulations; revises and maintains process documentation.
Supports GMP audits as a subject matter expert and coordinates communication with end users and suppliers.
Participates in cross-departmental projects, evaluates process trends for continuous improvement, and monitors manufacturing lines daily.
Provides training on process validation, develops validation strategies, and independently solves manufacturing issues.
Maintains compliance with environmental, safety, and occupational health policies.