Sr. Manufacturing Engineer (Medical Devices)

TL;DR

Sr. Manufacturing Engineer (Medical Devices): Engineering, design, and development of new neurovascular products and manufacturing processes with an accent on quality management systems and cross-functional project execution. Focus on optimizing operational systems, performing root cause analysis, and integrating new technologies into medical device production.

Location: Onsite in Alameda, CA

Salary: $113,000 – $157,000

Company

A medical technology company specializing in the development and manufacturing of neurovascular devices.

What you will do

• Lead cross-functional teams to plan and implement improvements to operational systems and production processes.
• Develop and document new processes for medical devices and components, including creating engineering protocols and reports.
• Execute project plans independently, managing risks and coordinating with Regulatory, Quality, R&D, and Supply Chain teams.
• Perform root cause analysis and troubleshooting to assess and implement corrective actions for production issues.
• Research and integrate new technologies into existing and future product lines.
• Create and modify product design specifications and technical drawings for production.

Requirements

• Bachelor’s degree in Mechanical, Biomedical, Electrical, Chemical, Materials, or Industrial Engineering.
• 4+ years of relevant engineering experience.
• Detailed knowledge of GMP, Quality System Regulations, and cleanroom environment practices.
• Strong understanding of engineering and scientific principles.
• Proficiency in Word, Excel, PowerPoint, and Access.

Nice to have

• Master’s degree in a relevant engineering field.
• Previous experience specifically within the medical device industry.
• Knowledge of FDA regulations and Lean/Flow Manufacturing principles.

Culture & Benefits

• Work environment includes a mix of general office, laboratory, and cleanroom settings.
• Opportunity to lead multidisciplinary project teams and mentor less experienced engineers.
• Focus on high-impact work within the neurovascular medical device domain.