Senior Mechanical Engineer

Surf Search Inc.; Denver (CO); On-site; USD 120,000 - 160,000; Full time

Benefits offered by this job

Restaurant d'entreprise

Indemnités de stage/alternance

Job summary

Surf Search Inc. seeks an experienced Senior Mechanical Engineer to join a medical device organization focused on diagnostic technologies.

You will work across the full product lifecycle from concept and design through testing, manufacturing and commercialization. You will design and optimize mechanical components and assemblies, provide production support, and lead investigations to improve performance, reliability, and cost efficiency while ensuring compliance with FDA, ISO, and EU MDR

Qualifications

• Bachelor's degree in Mechanical Engineering or related field.
• 8–15 years of relevant mechanical engineering experience.
• Experience with biocompatible materials, adhesives, and processing techniques.
• FDA, ISO, CE Mark, and EU MDR knowledge preferred.

Responsibilities

• Design, develop, and document mechanical components and systems for medical diagnostic devices.
• Provide engineering support for existing products and troubleshoot manufacturing challenges.
• Develop and optimize product designs, processes, and production fixtures.
• Create and execute test plans to evaluate function and compliance with specifications.
• Lead failure investigations and implement corrective actions to improve reliability.
• Support verification, validation, and regulatory compliance with FDA, ISO, EU MDR.
• Collaborate with cross-functional teams and suppliers to resolve technical challenges and document engineering work.

Skills

Analytical skills

Troubleshooting

Cross-functional communication

Mechanical design

Education

Bachelor's degree in Mechanical Engineering

Tools

SolidWorks

Job description

We are seeking an experienced Senior Mechanical Engineer to join an innovative medical device organization specializing in diagnostic technologies. This hands-on role offers the opportunity to work across the full product lifecycle, from concept and design through testing, manufacturing, and commercialization. The ideal candidate is a creative problem solver with strong mechanical design expertise and experience developing complex medical devices.

Requirements of the Senior Mechanical Engineer:

• Bachelor's degree in Mechanical Engineering or a related engineering discipline.
• 8–15 years of relevant mechanical engineering experience, preferably within the medical device industry.
• Proficiency in SolidWorks CAD software, including mechanical component and assembly design.
• Experience working with biocompatible materials, adhesives, and material processing techniques.
• Strong background in engineering mechanics, electromechanical design, and manufacturing processes.
• Experience designing production fixtures and supporting manufacturing process improvements.
• Excellent analytical, troubleshooting, technical documentation, and cross-functional communication skills.
• Knowledge of FDA, ISO, CE Mark, and EU MDR requirements preferred; experience with circuit design, flexible circuits, or miniature components is a plus.

Responsibilities of the Senior Mechanical Engineer:

• Design, develop, and document mechanical components and systems for advanced medical diagnostic devices.
• Provide engineering support for existing products, troubleshooting complex manufacturing and production challenges.
• Develop and optimize product designs, manufacturing processes, and production fixtures to improve performance, reliability, and manufacturability.
• Create and execute test plans to evaluate product functionality, performance, and compliance with specifications.
• Research and evaluate new materials, technologies, and manufacturing processes to enhance product quality and reduce costs.
• Lead failure investigations, identify root causes, and implement corrective actions to improve product reliability.
• Support product verification, validation, and regulatory compliance activities in accordance with FDA, ISO, and EU MDR requirements.
• Collaborate with cross-functional teams and external suppliers to resolve technical challenges, maintain engineering documentation, and support product commercialization.

Occupational Category: 17-2141 Mechanical Engineers