Key skills
AssemblyR
About this role
Role Overview
- Lead technical development of manufacturing processes for NPI programs, ensuring alignment with product development and production goals
- Design and implement manual and semi-automated workstations for feasibility builds and pilot production
- Scope, budget, and manage capital equipment projects, including vendor selection, procurement, installation, and validation
- Drive process optimization and automation readiness for transition from pilot builds to full-scale production
- Collaborate with R&D and Supplier Engineering to ensure product designs support manufacturability and automation (DFM/DFA)
- Develop specifications and validation protocols for automated assembly equipment (FAT/SAT, IQ/OQ/TMV/PQ)
- Support cross-functional teams in troubleshooting, continuous improvement, and technical problem-solving
- Ensure compliance with FDA regulations, ISO 13485, GMP, and internal quality standards
Requirements
- BS in Mechanical, Industrial, or Manufacturing Engineering with 10 + years of experience in manufacturing engineering or automation in a regulated industry
- MS in Engineering or Engineering Management with 8 + years of relevant experience preferred
- Experience with Class II medical devices and automated assembly systems is highly desirable
Tech Stack
- Assembly
Benefits
- Medical, dental, and vision insurance
- 401(k) with company match
- Paid time off (PTO)
- And additional employee wellness programs