Process Engineer

Arrotek Medical Ltd; North Attleborough (MA); Sur place; USD 110 000 - 150 000; Plein temps

Avantages offerts par ce poste

Career growth

Competitive benefits

Collaborative culture

Résumé du poste

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.

Responsabilités

• 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.

Connaissances

Injection molding

Mold flow analysis

Scientific molding

Regulatory knowledge

Problem solving

Formation

Bachelor's Degree in Plastics Engineering

Mechanical/Biomedical Engineering

Outils

Moldflow

SolidWorks Plastics

Description du poste

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.