Lead Injection Molding Process Engineer

Viant Medical; Vega Baja (PR); On-site; USD 90,000 - 125,000; Full time

Job summary

Viant Medical in the United States is seeking an Injection Molding Process Engineer to plan and coordinate equipment setup and processes for high quality molded products. The role supports new program launches, process validation, and continuous improvements while mentoring molding personnel.

The engineer will develop process documentation, provide technical leadership, and collaborate with vendors to resolve equipment issues, ensuring compliance with ISO 13485 and FDA requirements.

Qualifications

• BS degree in Science or related field.
• 5+ years’ relevant experience or 8+ years in medical device or equivalent.
• Experience with SPC, DOE, GR&R, PMEA, process validation (IQ, OQ, PQ) and FDA, ISO/MDD standards.
• Experience leading projects, coaching, and mentoring for engineering and technical team personnel.
• Strong written/verbal communication skills.
• Training experience to FDA regulations or ISO standards

Responsibilities

• Develop new processes, assess and document new and existing processes.
• Implement and evaluate changes to existing processes designed to improve product quality, productivity and overall equipment efficiency.
• Provide technical leadership and mentorship to process technicians, operators and other molding personnel.
• Develop and maintain process documentation ensuring that processes and procedures are clearly stated and understandable for all employees.
• Provide technical support/solutions to manufacturing processes, improve yield and throughput, drive cost reduction activities and improve on part quality from process standpoint.
• Demonstrated ability to start-up, operate and shut down process related equipment.

Skills

Process engineering

Project leadership

Molding knowledge

Education

BS degree in Science or related discipline

Tools

SPC

DOE

GR&R

PMEA

IQ/OQ/PQ

FDA/ISO standards

Job description

Viant Medical in the United States is seeking an Injection Molding Process Engineer to plan and coordinate equipment setup and processes for high quality molded products. The role supports new program launches, process validation, and continuous improvements while mentoring molding personnel.

The engineer will develop process documentation, provide technical leadership, and collaborate with vendors to resolve equipment issues, ensuring compliance with ISO 13485 and FDA requirements.