Manufacturing Engineer I (Medtech)

TL;DR

Manufacturing Engineer I (Medtech): Developing and optimizing manufacturing processes to commercialize medical products with an accent on root cause analysis, process validation, and production efficiency. Focus on designing fixtures, implementing innovative solutions on the production floor, and ensuring compliance with FDA and QMS regulations.

Location: Onsite in Roseville, CA

Salary: $72,000 – $94,000 per year

Company

Global healthcare company focused on innovative therapies for devastating diseases.

What you will do

• Solve production problems and implement innovative solutions using detailed root cause analysis.
• Design and implement fixtures, tooling, and equipment on the production line.
• Monitor process performance to optimize yield, efficiency, and throughput.
• Author protocols, perform process validations, and execute tests on raw materials and products.
• Develop product and process documentation and train staff on equipment and QMS.
• Ensure adherence to domestic and global quality system regulations, including FDA and QMS.

Requirements

• Bachelor’s degree in Mechanical, Biomedical, Electrical, Chemical, Materials, or Industrial Engineering.
• Must be able to work on site in Roseville, CA.
• 1+ year of relevant engineering experience preferred, ideally in the medical device industry.
• Excellent written and verbal communication skills.
• Proficiency in MS Office (Word, Excel, PowerPoint, Access).
• Knowledge of FDA regulations and Lean/Flow Manufacturing is desired.

Culture & Benefits

• Collaborative environment with constant learning and performance rewards.
• Comprehensive medical, dental, and vision insurance.
• 401(k) with employer match.
• Generous paid time off, including parental leave, sick time, and a minimum of 15 days of vacation.
• Eleven paid company holidays per year.