Senior Process Development Engineer — Scale Medical Devices

Theragenics Corp; North Attleborough (MA); On-site; USD 125,000 - 150,000; Full time

Benefits offered by this job

Competitive benefits package

Job summary

Theragenics Corp in North Attleboro, MA is seeking an Engineer – Process Development to lead the development, validation, and scale-up of manufacturing processes for medical devices. You will work across product development and manufacturing to ensure feasibility, quality, throughput, and compliance in prototype through full production stages.

Responsibilities include designing scalable processes, applying DFM/ DFA principles, troubleshooting manufacturing issues, and documenting procedures

Qualifications

• 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.

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/ISO13485

Metal processing

Precision machining

Hypotubes

Laser processing

Plastic injection molding

Cleanroom assembly

Tools

Tooling

Fixturing

Quality systems

Job description

Theragenics Corp in North Attleboro, MA is seeking an Engineer – Process Development to lead the development, validation, and scale-up of manufacturing processes for medical devices. You will work across product development and manufacturing to ensure feasibility, quality, throughput, and compliance in prototype through full production stages.

Responsibilities include designing scalable processes, applying DFM/ DFA principles, troubleshooting manufacturing issues, and documenting procedures