Manufacturing Engineer I (Medtech)

TL;DR

Manufacturing Engineer I (Medtech): Developing and optimizing manufacturing technology and robust solutions for electronics development in medical devices with an accent on process optimization, equipment qualification, and yield increase. Focus on executing root cause analysis, designing fixtures, and ensuring compliance with QMS and FDA regulations.

Location: Onsite in Alameda, CA

Salary: $80,000–$105,000

Company

A global healthcare company focused on innovative therapies for challenging medical conditions.

What you will do

• Implement innovative solutions and execute detailed root cause analysis to resolve production floor problems.
• Maintain product and process documentation while monitoring equipment performance to optimize yield and efficiency.
• Design fixtures, acquire tooling, and perform equipment qualifications and process validations.
• Develop product specifications and optimize processes using statistical techniques and engineering knowledge.
• Train assemblers, quality control, and technicians on processes, equipment, and documentation.
• Ensure strict adherence to the Quality Management System (QMS) and domestic/global quality regulations.

Requirements

• Bachelor’s degree in Mechanical, Biomedical, Electrical, Chemical, Materials, or Industrial Engineering.
• Must be able to work on site in Alameda, CA.
• 1+ year of relevant engineering experience preferred, with a preference for the medical device industry.
• Knowledge of FDA regulations and Lean/Flow Manufacturing processes.
• Proficiency in Word, Excel, PowerPoint, and Access.

Culture & Benefits

• Comprehensive benefits including medical, dental, vision, and life insurance.
• 401(k) plan with employer match.
• Paid parental leave, sick time, and eleven paid company holidays per year.
• Minimum of fifteen days of accrued vacation per year, increasing with tenure.
• Collaborative teamwork environment focused on revolutionizing disease treatment.