Engineer – Process Development

Salary Expectation

Based on the candidate's level of experience.

About the role

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.

Responsibilities

• Lead early-stage manufacturing strategy alongside product development to ensure scalability.
• Evaluate materials, risks, tolerances, and throughput during concept and prototype phases.
• 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.

Requirements

• 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.

Skills

• 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.

Qualifications

• 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.

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.

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.”

Pay

Competitive compensation based on experience and qualifications.

Schedule

Full-time position.

Benefits

• Health insurance
• Retirement plan
• Flexible work schedule
• Professional development opportunities
• Employee wellness programs