Senior Mechanical Engineer, Medical Devices (Diabetes)

Technika Search; San Diego (CA); On-site; USD 130,000 - 170,000; Full time

Job summary

Not disclosed is seeking a Sr. Mechanical Engineer to kick off the design improvement process as our diabetes management device moves toward commercialization.

The role involves hands-on design, leading a small team, and ensuring compliance with FDA/ISO standards while optimizing reliability and manufacturability through SolidWorks, HALT testing, and iterative prototyping.

Expect collaborative planning, risk assessment, and strong emphasis on documentation and cross-functional communication.

Qualifications

• Bachelor’s degree in mechanical engineering or related field.
• 8-10+ years of experience in the medical device industry.
• Hands-on individual contributor with small team collaboration.
• Proficiency with SolidWorks.
• Proficiency with Minitab.
• Python scripting to collect real-time pressure values with device health metrics.
• Thorough understanding of regulatory requirements for medical devices.
• Experience with plastic injection-molded parts at micron level.
• Knowledge of HALT testing and accelerated aging.
• Experience with Stress Analysis and micron-level stack-up.
• Familiarity with 5S, Fishbone, 5Y (5 Whys), and Fortree (Fault Tree Analysis) methodologies.
• Ability to write and execute test protocols.
• Demonstrated small medical device design experience.

Responsibilities

• Hands-on design and improvement of mechanical systems, components, and assemblies for medical devices.
• Plan, execute, and deliver mechanical engineering projects within timelines, budget constraints, and quality standards.
• Design and improve components and test fixtures using SolidWorks.
• Conduct engineering analysis, simulations, and testing for performance, reliability, and safety of mechanical designs.
• Identify and mitigate risks and ensure regulatory compliance throughout development lifecycle.
• Communicate project updates, technical findings, and recommendations to senior management and cross-functional teams.

Skills

SolidWorks

Minitab

Python scripting

Regulatory compliance

Problem solving

Education

Bachelor’s degree in mechanical engineering

Tools

SolidWorks

Minitab

Job description

Not disclosed is seeking a Sr. Mechanical Engineer to kick off the design improvement process as our diabetes management device moves toward commercialization.

The role involves hands-on design, leading a small team, and ensuring compliance with FDA/ISO standards while optimizing reliability and manufacturability through SolidWorks, HALT testing, and iterative prototyping.

Expect collaborative planning, risk assessment, and strong emphasis on documentation and cross-functional communication.