Experienced Manufacturing Engineer - Orthopedics

About the role

Johnson & Johnson MedTech's Orthopedics business is looking for an experienced Manufacturing Engineer in Alajuela, Costa Rica. The role executes engineering deliverables for large-scale manufacturing capacity projects that deliver stable, reliable and cost-effective manufacturing processes, covering project delivery and knowledge transfer to developing site staff. It works with existing functional organizations to standardize and implement best-in-class practices, and supports the manufacture of orthopedic implants for knee, hip and shoulder joint arthroplasty.

Key responsibilities

• Support delivery of fully developed and qualified orthopaedic implant manufacturing processes to Network Edge projects
• Ensure project activities follow QMS procedures and controls, and that product quality meets specified standards and regulatory requirements
• Collaborate with stakeholders on technical, validation and regulatory strategies at an appropriate risk level
• Coordinate project plans with internal and external partners and document project and program activities
• Support EHS&S policies and procedures, and follow company health, safety and environmental guidelines
• Make decisions on technical and management issues and lead on quality and compliance

Required profile

• Bachelor's degree or equivalent
• Minimum 2-4 years of relevant professional experience
• Experience in manufacturing of high-precision machined products in a highly regulated environment
• Experience with validation (IQ/OQ/PQ) and risk management documentation
• Effective communication in English and Spanish
• Primary on-site position in Alajuela, Costa Rica, second shift

Required skills

• Statistical and problem-solving engineering (Six Sigma, SE or A3)
• Good Manufacturing Practices (GMP) and Lean Manufacturing principles
• Project engineering and project schedule management