Manufacturing Engineer II

A Day in the Life

The Cranial & Spine Manufacturing Engineering function in Humacao, Puerto Rico supports the development, implementation, and improvement of manufacturing processes, equipment, tooling, and production methods that enable successful new product introduction and transfer of product and technology designs into manufacturing. The Manufacturing Engineer II partners with R&D, engineering, quality, and manufacturing teams to support new technologies and therapies from concept through launch, while maintaining product quality and regulatory compliance. This position is onsite in Humacao, Puerto Rico and requires less than 10% travel.

The Manufacturing Engineer II is an experienced individual contributor responsible for developing, implementing, and improving manufacturing processes, equipment, tooling, and production solutions in support of Cranial & Spine new product introduction and R&D initiatives. This role works independently on moderately complex projects, contributes to design transfer and launch readiness, recommends process improvements, and provides technical guidance to entry-level team members as needed.

Responsibilities

• Design and implement manufacturing processes, procedures, equipment, tooling, and production layouts for new products, existing products, and design transfer activities.
• Develop manufacturing solutions supporting R&D projects, new technologies, product designs, and transfer to manufacturing.
• Define sequences of operations and fabrication requirements for tooling and equipment to support product performance, manufacturability, and production readiness.
• Evaluate machinery, equipment, and tooling performance; investigate deficiencies; and implement corrective actions to support product quality and operational efficiency.
• Develop and improve manufacturing processes using Statistical Process Control (SPC), process capability methods, and other process control techniques.
• Incorporate inspection, testing, validation, and manufacturing requirements into production processes and plans.
• Partner with R&D and cross-functional engineering teams to provide input on design concepts, specifications, equipment selection, and manufacturing methods.
• Recommend process, equipment, and system improvements while ensuring manufacturing processes and procedures comply with applicable regulatory requirements.
• Support design transfer, process validation, and launch readiness activities for new products and technologies.
• Provide technical guidance and support to entry-level engineers and cross-functional partners as needed.

Required Qualifications

Bachelor’s degree in Engineering with 2+ years of relevant experience, or Master’s degree in Engineering with 0+ years of relevant experience.

Preferred Qualifications

• Experience in manufacturing process development, equipment, tooling, or new product introduction.
• Experience with Statistical Process Control (SPC), process capability, and manufacturing data analysis.
• Experience with Design for Manufacturing (DFM), process validation, or design transfer.
• Experience with Computer-Aided Design (CAD), Lean Manufacturing, or continuous improvement practices.
• Experience in medical device or other regulated manufacturing environments.