Senior Mechanical Engineer, Medical Devices - Design Leader

Technika Search; San Diego (CA); On-site; USD 150,000 - 210,000; Full time

Job summary

Technika Search in San Diego seeks a Sr. Mechanical Engineer to advance a diabetes management device, designed for simplicity and ease of use, easing transition from injections as commercialization begins.

You will lead hands-on design and improvement of mechanical systems, manage a small team, ensure HALT testing, regulatory compliance, and collaboration across design, manufacturing, and QA. Prototyping and real-time data collection with Python will be used to monitor performance.

Qualifications

• Bachelor's degree in mechanical engineering or related field.
• 8-10+ years in the medical device industry with hands-on contribution.
• Proficient in SolidWorks and Minitab, with Python scripting for data collection.
• Experience with plastic injection-molded parts at micron level.
• Understanding regulatory requirements for medical devices (FDA, ISO).
• Experience with design for reliability and HALT testing.

Responsibilities

• Design and improve mechanical components, assemblies, and test fixtures.
• Lead planning, execution, and delivery of mechanical projects within timelines and budgets.
• Mentor junior engineers and guide problem solving.
• Perform analyses, simulations, and testing for safety and performance.
• Ensure regulatory compliance throughout product development lifecycle.
• Identify and mitigate risks associated with mechanical engineering activities.
• Communicate progress and recommendations to management and cross-functional teams.

Skills

Leadership

HALT testing

Reliability design

Problem solving

Communication

Design for manufacturability

Education

Bachelor’s degree in mechanical engineering or related field

Tools

SolidWorks

Minitab

Python scripting

Job description

Technika Search in San Diego seeks a Sr. Mechanical Engineer to advance a diabetes management device, designed for simplicity and ease of use, easing transition from injections as commercialization begins.

You will lead hands-on design and improvement of mechanical systems, manage a small team, ensure HALT testing, regulatory compliance, and collaboration across design, manufacturing, and QA. Prototyping and real-time data collection with Python will be used to monitor performance.