Mechanical Design Engineer II (Manufacturing & Tooling – Medical Devices)

TL;DR

Mechanical Design Engineer II (Manufacturing & Tooling): Developing and optimizing manufacturing processes, tooling, and fixtures for medical device production with an accent on root cause analysis, equipment qualification, and continuous improvement. Focus on designing robust solutions that enhance production yield, efficiency, and throughput within a regulated cleanroom environment.

Location: Must be based on-site in Alameda, CA

Salary: $95,000–$120,000

Company

hirify.global is a global healthcare company focused on innovative therapies for patients with neurovascular and peripheral vascular conditions.

What you will do

• Design and implement new equipment, fixtures, and processes for medical device production.
• Perform root cause analysis to resolve production floor issues and implement vetted solutions.
• Monitor equipment performance and optimize manufacturing yield, efficiency, and throughput.
• Create and maintain detailed engineering designs, drawings, and technical documentation.
• Coordinate with suppliers and cross-functional teams to execute project phases.
• Train assemblers and technicians on new processes, equipment, and quality standards.

Requirements

• Bachelor's degree in Engineering or related technical field.
• Minimum 1+ years of relevant engineering experience.
• Must be willing and able to work on-site in Alameda, CA.
• Proficiency in Microsoft Office suite (Word, Excel, PowerPoint, Access).
• Strong organizational skills with the ability to manage multiple projects simultaneously.
• Excellent written and verbal communication skills.

Nice to have

• Experience in a manufacturing environment, preferably within the medical device industry.
• Knowledge of FDA regulations and quality system standards.
• Familiarity with Lean or Flow Manufacturing principles.

Culture & Benefits

• Competitive annual base salary.
• Comprehensive benefits package including health and wellness programs.
• Equity program participation where applicable.
• Opportunity to work in a high-tech, regulated medical device manufacturing environment.