Engineer – Process Development

Socket.dev; North Attleborough (MA); On-site; USD 110,000 - 190,000; Full time

Benefits offered by this job

Competitive benefits package.

Job summary

Theragenics in the United States is seeking an Engineer, Process Development to lead development, validation, and scaling of manufacturing processes for medical devices in a fast-paced environment.

You will collaborate with cross-functional teams, apply DFM/ DFA, and drive continuous improvement, ensuring compliance with FDA/ISO 13485 requirements while enabling scalable production.

Qualifications

• 7–10+ years in contract medical device or regulated manufacturing.
• Expertise in metal processing (precision machining, hypotubes, laser processing).
• Familiarity with plastic injection molding and cleanroom assembly operations.
• Hands-on capability in tooling, fixturing, and precision assembly.
• Knowledge of Lean Manufacturing, DOE, and statistical methods.
• Understanding of FDA and ISO 13485 regulated manufacturing requirements.

Responsibilities

• Lead early-stage manufacturing strategy alongside product development to ensure scalability.
• Establish feasibility during concept and prototype phases by evaluating materials, risks, tolerances, and throughput.
• Utilize rapid prototyping methods (machining, laser processing, additive manufacturing, molding).
• Develop scalable processes that transition effectively from prototype to full production.
• Apply Design for Manufacturability (DFM) and Design for Assembly (DFA) initiatives.
• Troubleshoot manufacturing issues using structured problem-solving and data-driven analysis.
• Design and implement fixtures, tooling, and process aids to improve robustness.
• Execute process verification and validation activities (IQ/OQ/PQ).
• Drive continuous improvement in yield, throughput, efficiency, and cost optimization.
• Prepare and maintain process documentation (work instructions, routings, PFMEAs, control plans).
• Support production readiness by transferring processes to operations and training personnel.

Skills

Lean Manufacturing

DOE

Statistical Methods

FDA/ISO 13485 knowledge

Metal Processing

Plastic Injection Molding

Cleanroom Assembly

Tooling & Fixturing

Cross-functional collaboration

Education

Bachelor's degree

Master's degree

Job description

Salary Expectation: Based on the candidate's level of experience.

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.

• Leader in medical devices for minimally invasive cancer treatments, blood vessel procedures, and surgical applications.
• Headquarters in Atlanta, Georgia, with facilities in Costa Rica, Texas, and Massachusetts.
• Proud operator of Arrotek, a visionary medical device design consultancy in the U.S. and Ireland, pioneering minimally invasive solutions that enhance lives.

Role Summary

As an Engineer, Process Development, you’ll play a pivotal role in developing, validating, and scaling manufacturing processes, collaborating with cross-functional teams to deliver practical, manufacturable, and compliant solutions in a fast-paced, customer-driven environment.

Key Responsibilities

• Lead early-stage manufacturing strategy alongside product development to ensure scalability.
• Establish feasibility during concept and prototype phases by evaluating materials, risks, tolerances, and throughput.
• Utilize rapid prototyping methods (machining, laser processing, additive manufacturing, molding).
• Develop scalable processes that transition effectively from prototype to full production.
• Apply Design for Manufacturability (DFM) and Design for Assembly (DFA) initiatives.
• Troubleshoot manufacturing issues using structured problem-solving and data-driven analysis.
• Design and implement fixtures, tooling, and process aids to improve robustness.
• Execute process verification and validation activities (IQ/OQ/PQ).
• Drive continuous improvement in yield, throughput, efficiency, and cost optimization.
• Prepare and maintain process documentation (work instructions, routings, PFMEAs, control plans).
• Support production readiness by transferring processes to operations and training personnel.

Qualifications & Skills

• Education: Bachelor’s degree required; master’s preferred.
• Experience:
  • 7–10+ years in contract medical device or regulated manufacturing environment.
  • Expertise in metal processing (precision machining, hypotubes, laser processing).
  • Familiarity with plastic injection molding and cleanroom assembly operations.
  • Hands‑on capability in tooling, fixturing, and precision assembly.
  • Knowledge of Lean Manufacturing, DOE, and statistical methods.
  • Understanding of FDA and ISO 13485 regulated manufacturing requirements.

Core Competencies

• Technical capability in process development.
• Validation, quality, and regulatory alignment.
• Problem‑solving and continuous improvement.
• Cross‑functional collaboration and communication.
• Execution discipline in documentation and prioritization.

Why Join Us

• Career growth opportunities in a global healthcare leader.
• Work on innovative projects that directly impact patient lives.
• Collaborative, supportive culture with cross-functional teamwork.
• Competitive benefits package.
• Purpose-driven work: “We don’t just ship inventory; we deliver care.”
• A mission that blends high-tech and human impact: “Healthcare that is both high-tech and human, with a global reach but a personal impact.”