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
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Develop, optimize, and implement manufacturing processes for minimally invasive medical devices.
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Provide daily technical support including troubleshooting equipment, materials, and processes.
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Lead initiatives for process capability improvement, cycle time reduction, and scrap reduction.
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Design and fabricate custom fixtures, tooling, and work-holding solutions.
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Conduct process characterization and validation (IQ/OQ/PQ).
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Evaluate and improve equipment utilization, workflow, and labor efficiency.
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Support Lean manufacturing and continuous improvement activities.
Hands-On Prototyping & Fabrication
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Perform hands-on prototype fabrication including machining, assembly, bonding, and reflow processing.
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Build and iterate engineering prototypes and pilot builds.
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Operate and troubleshoot lab and production equipment.
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Develop repeatable assembly processes for precision components.
Product Development Support
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Collaborate with design engineers to ensure manufacturability (DFM/DFA).
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Support early-stage prototyping and feasibility builds.
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Generate work instructions and process documentation.
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Participate in design reviews and risk assessments.
Manufacturing Transfer & Validation
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Support transfer to manufacturing including documentation and training.
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Execute process validations and verification studies.
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Support inspection method development.
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Ensure compliance with FDA and ISO 13485 requirements.
Data Analysis & Continuous Improvement
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Analyze process data to identify improvements.
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Lead root cause investigations and corrective actions.
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Identify cost reduction opportunities.
Requirements
Education
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Associate or Bachelor’s Degree in Engineering or a related field.
Experience
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8–12+ years in medical device manufacturing or process engineering.
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Strong background in process development and troubleshooting.
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Experience in regulated environments (FDA / ISO 13485).
Technical Skills
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Hands-on machining, fixturing, and tooling development.
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Precision assembly processes.
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Equipment troubleshooting and process setup.
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CAD (e.g., SolidWorks) is helpful but secondary.
Why Join Us
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Work on innovative projects that directly impact patient care.
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Collaborate with engineers and cross-functional teams in a dynamic environment.
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Opportunities for career growth and skill development.
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Competitive benefits and a supportive, purpose-driven culture.
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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.
