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

Benefits

Medical, dental, and vision insurance
401(k) with company match
Paid time off (PTO)
And additional employee wellness programs

Applicant Tracking System Keywords

Tip: use these terms in your resume and cover letter to boost ATS matches.

Hard Skills & Tools

manufacturing processesNPI programsmanual workstationssemi-automated workstationscapital equipment projectsprocess optimizationautomation readinessautomated assembly equipmentvalidation protocolstroubleshooting

Soft Skills

collaborationcontinuous improvementtechnical problem-solvingproject management

Certifications

BS in Mechanical EngineeringBS in Industrial EngineeringBS in Manufacturing EngineeringMS in EngineeringMS in Engineering Management