Senior Process Engineer - Injection Molding (Onsite)

Viant Medical Inc.; Vega Baja (PR); On-site; USD 85,000 - 115,000; Full time

Job summary

Viant Medical Inc. seeks an experienced Process Engineer to develop and document new and existing manufacturing processes for medical devices.

You will assess processes, implement improvements for quality, productivity, and equipment efficiency, and provide technical leadership to molding personnel. You will collaborate with vendors and cross-functional teams, maintain process documentation, and apply statistical methods to meet cost, quality, and delivery goals.

Qualifications

• BS degree in Science or related discipline.
• 5+ years of relevant experience, or 8+ years in medical device or equivalent.
• Experience with SPC, DOE, GR&R, PMEA, and process validation (IQ, OQ, PQ).
• Knowledge of FDA and ISO/MDD standards.
• Leading projects and mentoring engineering teams.
• Strong communication and teamwork skills.

Responsibilities

• Develop and document new and existing processes to improve quality and productivity.
• Provide technical leadership to process technicians, operators and molding personnel.
• Create process documentation such as process sheets and validation documents.
• Support manufacturing with process control improvements and cost-reduction initiatives.
• Ensure regulatory compliance with FDA and ISO standards on the production floor.
• Lead continuous improvement projects across functions.

Skills

Statistical Process Control

DOE

GR&R

PMEA

Process Validation

FDA & ISO Standards

Education

BS in Science or related discipline

Job description

Viant Medical Inc. seeks an experienced Process Engineer to develop and document new and existing manufacturing processes for medical devices.

You will assess processes, implement improvements for quality, productivity, and equipment efficiency, and provide technical leadership to molding personnel. You will collaborate with vendors and cross-functional teams, maintain process documentation, and apply statistical methods to meet cost, quality, and delivery goals.