Senior Associate Engineer - Process Development
Job in
Attleboro Falls, Bristol County, Massachusetts, 02763, USA
Listed on 2026-06-14
Listing for:
Theragenics
Full Time
position Listed on 2026-06-14
Job specializations:
-
Engineering
Manufacturing Engineer, Process Engineer, Quality Engineering, Mechanical Engineer
Job Description & How to Apply Below
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.
- 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.
- 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.
- 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.
- Analyze process data to identify improvements.
- Lead root cause investigations and corrective actions.
- Identify cost reduction opportunities.
Education
- Associate or Bachelor's Degree in Engineering or a related field.
- 8-12+ years in medical device manufacturing or process engineering.
- Strong background in process development and troubleshooting.
- Experience in regulated environments (FDA / ISO 13485).
- Hands-on machining, fixturing, and tooling development.
- Precision assembly processes.
- Equipment troubleshooting and process setup.
- CAD (e.g., Solid Works) is helpful but secondary.
- 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.
Position Requirements
10+ Years
work experience
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