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Principal Mechanical Engineer/Lead

2 months ago


San Diego, United States Technika Search Full time

Our client is the leading developer of a diabetes management device designed for simplicity, allowing for discrete insulin injection and data sharing with healthcare providers. It is designed 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.

ROLE AND RESPONSIBILITIES

• Team Leadership: Lead, mentor, and inspire a small team of mechanical engineers, fostering a

culture of innovation, collaboration, and continuous improvement.

Project Management: Oversee the planning, execution, and delivery of mechanical

engineering projects, ensuring adherence to timelines, budget constraints, and quality

standards.

• Mechanical Design: Provide technical expertise in the design and development of

mechanical systems, components, and assemblies for medical devices, incorporating

principles of engineering design, materials science, and manufacturing processes.

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

Problem Solving: Developing and executing plan for solving of complex design problems. Delegating sub-problems to Engineering team, guiding Jr. Engineers on solving problems and in some cases solving challenging issues for them.

• 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.

• 10+ years of experience in the medical device industry, with a strong track record of

successfully collaborating and leading at least 2-3 direct reports.

• High level of proficiency with SolidWorks.

Experienced with a wide breadth of Medical Device development design issues.

•Thorough understanding of regulatory requirements for medical devices.

• Strong analytical skills, with the ability to solve complex engineering problems, interpret

technical data, and make datadriven decisions.

• Demonstrated leadership abilities, including coaching, mentoring, and developing

engineering talent.