Senior Associate Engineer – Process Development in North Attleboro, Massachusetts at Theragenics Corp

Purpose of Job

The Senior Associate Engineer – Process Development will support Arrotek (USA)’s Design Services and Manufacturing teams during a period of rapid growth. This role is responsible for hands-on development, prototyping, and process optimization of minimally invasive medical devices, with a strong emphasis on manufacturing process development, equipment capability, and production readiness.

This individual serves as a bridge between product development and manufacturing by developing robust processes, troubleshooting technical challenges, and ensuring efficient transfer of products into scalable production.

Essential Job Duties

Process Development & Manufacturing Support

• Develop, optimize, and implement manufacturing processes for minimally invasive medical devices.
• Provide daily technical support including troubleshooting equipment, materials, and processes.
• Lead initiatives for process capability improvement, cycle time reduction, and scrap reduction.
• Design and fabricate custom fixtures, tooling, and work-holding solutions.
• Conduct process characterization and validation (IQ/OQ/PQ).
• Evaluate and improve equipment utilization, workflow, and labor efficiency.
• Support Lean manufacturing and continuous improvement activities.

Hands-On Prototyping & Fabrication

• Perform hands-on prototype fabrication including machining, assembly, bonding, and reflow processing.
• Build and iterate engineering prototypes and pilot builds.
• Operate and troubleshoot lab and production equipment.
• Develop repeatable assembly processes for precision components.

Product Development Support

• Collaborate with design engineers to ensure manufacturability (DFM/DFA).
• Support early-stage prototyping and feasibility builds.
• Generate work instructions and process documentation.
• Participate in design reviews and risk assessments.

Manufacturing Transfer & Validation

• Support transfer to manufacturing including documentation and training.
• Execute process validations and verification studies.
• Support inspection method development.
• Ensure compliance with FDA and ISO 13485 requirements.

Data Analysis & Continuous Improvement

• Analyze process data to identify improvements.
• Lead root cause investigations and corrective actions.
• Identify cost reduction opportunities.

Requirements

Education

• Associate or Bachelor’s Degree in Engineering or a related field.

Experience

• 8–12+ years in medical device manufacturing or process engineering.
• Strong background in process development and troubleshooting.
• Experience in regulated environments (FDA / ISO 13485).

Technical Skills

• Hands-on machining, fixturing, and tooling development.
• Precision assembly processes.
• Equipment troubleshooting and process setup.
• CAD (e.g., SolidWorks) is helpful but secondary.

Why Join Us

• Work on innovative projects that directly impact patient care.
• Collaborate with engineers and cross-functional teams in a dynamic environment.
• Opportunities for career growth and skill development.
• Competitive benefits and a supportive, purpose-driven culture.
• Be part of a mission that matters—developing prototypes that contribute to life-saving medical devices.

Ready to make a difference? Apply today and help shape the future of healthcare innovation.