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

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Process Engineer

Full Time Individual Contributor Professional Arrotek US MA, North Attleboro, MA, US

3 days ago Requisition ID: 1230

Salary Range: $120,000.00 To $150,000.00 Annually

Be part of a mission that matters—join Theragenics as a Senior Engineer - Molding Process Development and help drive the production of life-saving medical devices used in cutting-edge treatments.

In this critical role, you'll lead plastic molding and overmolding process development from early feasibility through validated production transfer, contributing directly to the creation of minimally invasive solutions that improve and extend lives. If you're passionate about technology, precision, and making a meaningful impact in healthcare, this is your opportunity to help shape the future of patient care.

Company Overview:

At Theragenics, we're passionate about transforming healthcare and enhancing patient outcomes. Our commitment to innovation drives us to push the boundaries of what's possible, ensuring a brighter future for patients everywhere. Theragenics is a leader in developing medical devices that focus on minimally invasive treatments for cancer, blood vessel procedures, and surgical applications. The company is based in Atlanta, Georgia, and has facilities in Costa Rica, Texas, and Massachusetts. Theragenics proudly operates Arrotek, a visionary medical device design consultancy in the U.S. and Ireland, dedicated to pioneering minimally invasive solutions that enhance lives.

Role Summary:

As a Senior Engineer - Molding Process Development, you’ll play a pivotal role in driving plastic molding and overmolding process optimization, collaborating with cross-functional teams and external partners to deliver cutting-edge solutions in medical device component manufacturing.

Key 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 (parting line, gating, cooling, steel-safe conditions, etc.) 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.

Qualifications & Skills:

• Education: Bachelor's Degree in Plastics, Mechanical, Manufacturing, Biomedical Engineering, or a related technical discipline.
• Experience: Minimum 7 years of relevant experience in injection molding, mold engineering, or medical device manufacturing.
• Technical Expertise: Strong background in scientific molding principles, mold flow analysis (Moldflow, SolidWorks Plastics), and engineering/medical-grade polymers (PEEK, TPU, PC, Nylon).
• Regulatory Knowledge: Familiarity with FDA QSR/QMSR expectations, ISO 13485, process validation, design controls, and risk management.
• Preferred Attributes: RJG/Paulson or equivalent scientific molding training, hands-on shop-floor mindset, and experience with micro-molding or catheter components.

Why Join Us:

• Career Growth: Lead high-impact engineering initiatives and mentor upcoming talent in a rapidly expanding field.
• Innovative Projects: Work at the forefront of medical device design, tackling complex overmolding and micro-molding challenges.
• Collaborative Culture: Partner closely with cross-functional teams, global manufacturing facilities, and external customers.
• Competitive Benefits: Enjoy comprehensive rewards designed to support your health, well-being, and financial future.
• Purpose-Driven Work: Every project you touch directly contributes to life-saving medical treatments and better patient care.