Senior Process Development Engineer, Medical Devices

Theragenics; North Attleborough (MA); On-site; USD 120,000 - 180,000; Full time

Benefits offered by this job

Competitive benefits package

Career growth opportunities

Collaborative culture

Job summary

Theragenics seeks an Engineer, Process Development to lead the scaling of manufacturing processes for life-saving medical devices. You will collaborate with cross-functional teams to translate early-stage concepts into feasible, compliant production methods spanning prototype to full production.

In this role, you’ll apply DFM/ DFA, drive process verification, and push continuous improvements in yield and cost.

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

Metal processing

Injection molding

Lean Manufacturing

DOE

Statistical methods

FDA/ISO 13485

Tooling & fixturing

Regulatory alignment

Job description

Theragenics seeks an Engineer, Process Development to lead the scaling of manufacturing processes for life-saving medical devices. You will collaborate with cross-functional teams to translate early-stage concepts into feasible, compliant production methods spanning prototype to full production.

In this role, you’ll apply DFM/ DFA, drive process verification, and push continuous improvements in yield and cost.