Sr Mechanical Engineer - Medical Device

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

Our client is the leading developer of a diabetes management device designed for simplicity, for those who want an insulin pump that removes complicated technology and allows for a smooth transition from manual injections. We are dedicated to helping people with diabetes gain access to high-quality care by making it affordable and easy to use. This is an exciting time and as our Sr. Mechanical Engineer, you will kick off the design improvement process as our product travels the path of commercialization.

ROLE AND RESPONSIBILITIES

Team: As a hands-on Sr. team member, you will participate in hands-on design and improvement of mechanical systems, components, and assemblies for medical devices. You will incorporate principles of engineering design, materials science, and manufacturing processes, and inspire a small team of mechanical engineers, fostering a culture of innovation, collaboration, and continuous improvement.

Project Management: Participate inplanning, execution, and delivery of mechanical engineering projects, ensuring adherence to timelines, budget constraints, and quality standards from design change to manufacturing.

Mechanical Design: Provide technical expertise in the design and improvement of Mechanical components, assemblies, and test fixtures using SolidWorks

• Design for Reliability: Strong Knowledge of HALT testing and accelerated aging Testing. Ability to rapidly prototype and evaluate designs.

Problem Solving: Developing and executing plan for solving of complex design problems. Delegating sub-problems and guiding Jr. Engineers on solving problems.

Engineering Analysis: Conduct engineering analysis, simulations, and testing to evaluate the performance, reliability, and safety of mechanical designs, identifying opportunities for optimization and enhancement.

Regulatory Compliance: Ensure compliance with relevant regulatory standards and requirements (e.g., FDA regulations, ISO standards) throughout the product development lifecycle, maintaining accurate documentation and records.

Risk Management: Identify and mitigate risks related to mechanical engineering activities, proactively addressing technical challenges and ensuring the successful resolution of issues.

Communication: Effectively communicate project updates, technical findings, and strategic recommendations to senior management, cross-functional teams, and external stakeholders as needed.

QUALIFICATIONS AND EDUCATION REQUIREMENTS

• Bachelor’s degree in mechanical engineering or related field.
• 8-10+ years of experience in the medical device industry, with a strong track record of
• successfully collaborating on small teams as a hands-on individual contributor.
• High level of proficiency with SolidWorks.
• High level of proficiency with Minitab
• Proficiency with Python scripting in order to collect real-time pressure values alongside environmental and device health metrics in accordance with design change.
• Experienced with a wide breadth of Medical Device development design issues.
• Thorough understanding of regulatory requirements for medical devices.
• Must have experience with plastic injection-molded parts at micron level.
• Microfluidics Design an added benefit.
• Must have experience with Stress Analysis, Stack Up Analysis at Micron level.
• Must have the ability to work with the team to write and execute test protocols.
• Must have experience with 5S, Fishbone, 5Y (5 Whys), and Fortree (Fault Tree Analysis)methodologies.
• Demonstrated Small Medical Device design experience and ability to share images of products designed.