Manufacturing Engineer I

TL;DR

Manufacturing Engineer I (Medical Devices): Provide manufacturing technology and robust solutions to commercialize new products and support continuous improvement in production with an accent on process optimization, equipment qualification, and quality systems. Focus on solving production floor problems, implementing innovative solutions, and performing process validations using statistical techniques.

Location: Alameda, CA (onsite required)

Annual Base Salary: $80,000 to $105,000

Company

Global healthcare company focused on innovative therapies, designing, developing, manufacturing, and marketing products for challenging medical conditions.

What you will do

• Solve problems and implement innovative solutions through detailed root cause analysis.
• Support production by creating and maintaining documentation, monitoring performance, and implementing improvements for yield, efficiency, and throughput.
• Design fixtures, acquire tooling, implement fixturing, and perform equipment qualifications.
• Test processes, equipment, materials, and products; author protocols, execute validations, and make recommendations.
• Develop and optimize processes using statistical techniques; coordinate with suppliers for improvements.
• Plan, schedule, and coordinate engineering projects; train assemblers and technicians.

Requirements

• Bachelor’s degree in Mechanical, Biomedical, Electrical, Chemical, Materials, or Industrial Engineering or equivalent.
• 1+ year relevant engineering experience preferred; manufacturing or medical device industry recommended.
• Excellent written, verbal, and interpersonal communication skills.
• Proficiency in Word, Excel, PowerPoint, Access, and other computer applications.
• Adhere to Quality Management System (QMS), FDA regulations, security, privacy, and compliance standards.

Nice to have

• Knowledge of FDA regulations, Lean/Flow Manufacturing, materials, and manufacturing processes.

Culture & Benefits

• Collaborative teamwork environment with constant learning and performance rewards.
• Medical, dental, vision, life, AD&D, short/long-term disability insurance.
• 401(k) with employer match, paid parental leave, eleven paid holidays, minimum fifteen days vacation increasing with tenure, paid sick time.