Engineer – Process Development
About The Position
Be part of a mission that matters—join Theragenics as an Engineer, Process Development and help drive the optimization and scale-up of manufacturing processes that support life-saving medical devices. In this critical role, you’ll integrate manufacturing strategy early in product development to ensure feasibility, quality, efficiency, and scalability across prototype, pilot, and full production phases. If you’re passionate about precision engineering, innovation, and making a meaningful impact in healthcare, this is your opportunity to help shape the future of patient care. 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. 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.
Requirements
- Bachelor’s degree required; master’s preferred.
- 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.
- 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.
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.
Benefits
- 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.
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What This Job Offers
Job Type
Full-time
Career Level
Senior
