Onsite Lead Injection Molding Process Engineer

Viant Medical; Vega Baja (PR); On-site; USD 90,000 - 130,000; Full time

Job summary

Viant Medical is seeking an Injection Molding Process Engineer to plan and coordinate equipment setup and molding processes, producing high-quality medical devices. The role includes mentoring molding staff, leading process improvements, and documenting procedures to ensure compliance with FDA and ISO standards.

The successful candidate will support new program launches, quantify results, prepare reports, and collaborate across functions to drive continuous improvement and patient safety.

Qualifications

• BS degree requirement.
• 5+ years’ relevant experience and/or 8+ years in medical device or equivalent.
• Demonstrated knowledge on 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.
• Preferred: Six Sigma problem solving methodologies and/or ASQ certification.

Responsibilities

• Develop new processes, assess and document new and existing processes.
• Implement and evaluate changes to improve product quality, productivity and OEE.
• Provide technical leadership and mentorship to process technicians, operators and other molding personnel.
• Develop and maintain process documentation such as process sheets and validation docs.
• Provide technical support to manufacturing processes, improve yield and throughput, and drive cost-reduction activities.
• Start-up, operate, and troubleshoot injection molding equipment; work independently on new process development and on current production issues.

Skills

SPC

DOE

GR&R

PMEA

Process validation IQ/OQ/PQ

FDA ISO/MDD standards

Leadership

Education

BS in Science or related discipline

Job description

Viant Medical is seeking an Injection Molding Process Engineer to plan and coordinate equipment setup and molding processes, producing high-quality medical devices. The role includes mentoring molding staff, leading process improvements, and documenting procedures to ensure compliance with FDA and ISO standards.

The successful candidate will support new program launches, quantify results, prepare reports, and collaborate across functions to drive continuous improvement and patient safety.