Senior Manufacturing Engineer- Orthopedics
About The Position
Johnson & Johnson MedTech is seeking a Senior Manufacturing Engineer to support digital and manufacturing operations in Palm Beach Gardens, Florida. This role supports robotics, process development, tool design, manufacturing flow, continuous improvement, and engineering support of production. The Senior Manufacturing Engineer provides direction and technical support for equipment design and development, testing of materials, preparation of specifications and operator instructions, process studies, investigations, root cause analysis, problem solving, report and presentation preparation, project management, statistical analysis, presentation of data, and technical writing. This role also supports the implementation of new technologies, process development, evaluation of process quality, cost, capacity, and capability alternatives, while ensuring manufacturing areas meet quality standards, compliant documentation requirements, capacity, product availability, and cost objectives.
Requirements
- Bachelor of Science degree from an accredited institution in Manufacturing Engineering, Mechanical Engineering, Industrial Engineering, or a related degree is required.
- 2-4 years of experience in manufacturing and/or engineering is required.
- Demonstrated knowledge of manufacturing principles, practices, and procedures.
- Experience supporting process development, manufacturing flow, tooling, fixtures, equipment, and production engineering activities.
- Ability to lead investigations, perform root cause analysis, and solve complex process problems.
- Ability to deliver clear oral and written communications around process improvement projects.
- Strong organizational, project management, troubleshooting, analytical, interpersonal, and computer skills, including Microsoft Office, Minitab, and Visio.
Nice To Haves
- Master of Science degree from an accredited institution in Manufacturing Engineering, Mechanical Engineering, Industrial Engineering, or a related degree is preferred.
- Previous experience working in a regulated industry, such as medical device, is preferred.
- Experience in the medical device industry or medical field is preferred.
- Familiarity with FDA, GMP, and ISO requirements is preferred.
- Six Sigma or Lean Sigma certification or 4 years of related experience is preferred.
- Six Sigma Black Belt and Lean certifications are preferred.
Responsibilities
- Serve as a fully competent engineer in conventional aspects of the assigned subject matter, functional area, and responsibilities.
- Participate in multi-site projects and lead complex engineering projects, either technically or with an extensive cross-functional team.
- Develop and execute project plans and schedules, meet project goals and objectives, track costs, prepare status reports, conduct meetings, and document and communicate progress to management.
- Lead and participate in investigations, develop plans, and execute tasks to solve process problems, including nonconformances, complaint investigations, audit observations, and corrective and preventive actions.
- Perform analysis and communicate associated trends.
- Provide day-to-day support and direction to Production, including turning, milling, drilling, EDM, finishing, packaging, and other manufacturing activities as required.
- Develop process validation strategy and lead validation execution, including engineering studies, process validation protocols, and summary reports.
- Write and execute Installation Qualification, Operational Qualification, Performance Qualification, Computer Software Validation, and Test Method Validation documentation.
- Identify, lead, and implement process improvements for existing manufacturing processes using appropriate engineering principles and standard strategies, including Lean and Six Sigma principles.
- Perform gage design, measurement system analysis, and gage implementation as required.
- Use measuring instruments such as micrometers, calipers, comparators, tensile testers, coordinate measurement systems, and other tools to support engineering testing.
- Lead the design and development of fixtures and tools and collaborate effectively with tool designers to express and implement ideas.
- Lead new equipment acquisition efforts, including user requirement specifications, machine selection, installation, validation, employee training, and related equipment responsibilities.
- Develop and implement manufacturing and inspection procedures.
- Participate in and lead cross-functional teams, which may include Manufacturing Engineering, Production, Quality Assurance, Finance, Product Development, and personnel from other sites.
- Act as a liaison to vendors regarding contracted products, tools, fixtures, and manufacturing support.
- Identify and implement improvements to engineering business processes, including configuration management, ERP management, maintenance tracking, and related systems.
- Perform other related duties as required.
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What This Job Offers
Job Type
Full-time
Career Level
Senior
