Senior Medical Device Molding Process Engineer

Theragenics Corp; North Attleborough (MA); On-site; USD 120,000 - 150,000; Full time

Benefits offered by this job

Competitive benefits

Career growth

Collaborative culture

Job summary

Theragenics Corp. is seeking a Senior Engineer - Molding Process Development in Massachusetts to lead plastic molding and overmolding process development from feasibility through transfer to production.

You will collaborate with cross-functional teams and external partners to deliver medical device components of the highest quality. The role requires a strong background in scientific molding, mold flow analysis, and regulatory compliance with FDA QSR/QMSR and ISO 13485.

Qualifications

• Bachelor's degree in plastics/mechanical/biomedical engineering or related field.
• Minimum 7 years in injection molding or medical device manufacturing.
• Experience 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 development onto metal tubes, hypotubes, wireforms, cannulae, and precision medical substrates.
• Drive transfer from prototype to production, including T0/T1/T2 sampling, process characterization, and capability analysis.
• Own validation deliverables, including IQ/OQ/PQ strategy, protocols, reports, and compliance with FDA/ISO 13485 standards.
• Troubleshoot complex molding issues (flash, knit lines, sink, warpage, adhesion) and perform DFM/DFA evaluations with design engineers and customers.
• Serve as a primary technical interface with customers on molding feasibility, risks, and validation readiness.

Skills

Scientific molding principles

Mold flow analysis

FDA QSR/QMSR knowledge

Risk management

Cross-functional collaboration

Troubleshooting molding issues

Education

Bachelor's degree in Plastics/Mechanical/Manufacturing/Biomedical Engineering or related field

Tools

Moldflow

SolidWorks Plastics

Job description

Theragenics Corp. is seeking a Senior Engineer - Molding Process Development in Massachusetts to lead plastic molding and overmolding process development from feasibility through transfer to production.

You will collaborate with cross-functional teams and external partners to deliver medical device components of the highest quality. The role requires a strong background in scientific molding, mold flow analysis, and regulatory compliance with FDA QSR/QMSR and ISO 13485.