Senior Molding Process Engineer - Medical Devices

Theragenics; North Attleborough (MA); On-site; USD 90,000 - 120,000; Full time

Benefits offered by this job

Career growth

Innovative projects

Collaborative culture

Competitive benefits

Purpose-driven work

Job summary

Theragenics is seeking a Senior Engineer - Molding Process Development to advance plastic molding and overmolding for critical medical devices. You will lead DOE-based optimization, guide tooling reviews, and coordinate with internal teams and external fabricators.

In this on-site role in Massachusetts, you will drive prototype-to-production transfers, manage IQ/OQ/PQ validation, and address complex molding challenges to ensure high-quality, compliant components for life-saving therapies.

Qualifications

• Bachelor's degree in a related engineering discipline.
• Minimum 7 years of experience in injection molding, mold engineering, or medical device manufacturing.
• Strong background in scientific molding, mold flow analysis, and engineering/medical-grade polymers.
• Familiarity with FDA QSR/QMSR, ISO 13485, process validation, and risk management.

Responsibilities

• Lead molding process development and DOE-based optimization for plastic injection molded and insert/overmolded medical device components.
• Support tooling strategy and mold design reviews with internal teams and external fabricators.
• Specialize in overmolding onto metal tubes, hypotubes, wireforms, cannulae, and precise substrates.
• Drive transfer from prototype to production with sampling, process characterization, and capability analysis.
• Own validation deliverables including IQ/OQ/PQ strategy and FDA/ISO 13485 compliance.

Skills

Teamwork mindset

Problem solving

Education

Bachelor's Degree in Plastics, Mechanical, Manufacturing, Biomedical Engineering

Tools

Moldflow

SolidWorks Plastics

Job description

Theragenics is seeking a Senior Engineer - Molding Process Development to advance plastic molding and overmolding for critical medical devices. You will lead DOE-based optimization, guide tooling reviews, and coordinate with internal teams and external fabricators.

In this on-site role in Massachusetts, you will drive prototype-to-production transfers, manage IQ/OQ/PQ validation, and address complex molding challenges to ensure high-quality, compliant components for life-saving therapies.