Quality Process Engineer – Injection Molding & NPI

Aptyx

Torrington (CT)

On-site

USD 85,000 - 130,000

Full time

4 days ago

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Job summary

Aptyx is seeking a Process Engineer – Quality Focus to lead the development, validation, and ongoing control of manufacturing processes for plastic injection molding and secondary operations in a regulated medical device environment.

You will partner with Quality, Production, Tooling, Maintenance, Engineering, and Program Management to support daily manufacturing, new product introductions, and continuous improvement while maintaining process capability and compliance with ISO 13485 and FDA

Qualifications

Bachelor's degree in Mechanical, Plastics, Manufacturing Engineering or related field.
3–7 years in manufacturing/ process engineering.
Experience in plastic injection molding and regulated environments.
Medical device manufacturing experience preferred.

Responsibilities

Develop, optimize, and maintain robust injection molding and secondary processes.
Define validated process windows and control strategies to ensure product quality.
Lead process validations (IQ, OQ, PQ) in compliance with medical device regs.
Support change controls for materials, tooling, equipment, and processes.
Collaborate with Quality, Production, Tooling, and Engineering on investigations and CAPAs.