Senior Molding Process Engineer for Medical Devices

Arrotek Medical Ltd; North Attleborough (MA); On-site; USD 110,000 - 150,000; Full time

Benefits offered by this job

Career growth

Competitive benefits

Collaborative culture

Job summary

Theragenics seeks a Senior Engineer - Molding Process Development to lead plastic molding and overmolding process development for medical device components. You will drive DOE optimization, tooling reviews, and prototype-to-production transfer with cross-functional teams and external partners.

The role requires a bachelor’s in plastics/engineering and 7+ years in injection molding or medical device manufacturing, with strong regulatory knowledge (FDA/ISO 13485) and hands-on problem solving.

Qualifications

• Bachelor's or higher in plastics, mechanical, manufacturing or biomedical engineering.
• Minimum 7 years of injection molding, mold engineering, or medical device manufacturing.

Responsibilities

• Lead molding process development and DOE-based optimization for injection molded components.
• Review tooling strategy and mold design with internal teams and external fabricators.
• Specialize in overmolding onto metal tubes and precision substrates.
• Drive transfer from prototype to production including sampling and validation.
• Own IQ/OQ/PQ strategy, protocols, and FDA/ISO 13485 compliance.
• Troubleshoot molding issues and perform DFM/DFA evaluations with engineers.

Skills

Injection molding

Mold flow analysis

Scientific molding

Regulatory knowledge

Problem solving

Education

Bachelor's Degree in Plastics Engineering

Mechanical/Biomedical Engineering

Tools

Moldflow

SolidWorks Plastics

Job description

Theragenics seeks a Senior Engineer - Molding Process Development to lead plastic molding and overmolding process development for medical device components. You will drive DOE optimization, tooling reviews, and prototype-to-production transfer with cross-functional teams and external partners.

The role requires a bachelor’s in plastics/engineering and 7+ years in injection molding or medical device manufacturing, with strong regulatory knowledge (FDA/ISO 13485) and hands-on problem solving.