Senior Mechanical Engineer - Medical Diagnostics & Devices

Surf Search Inc.

Denver (CO)

On-site

USD 120,000 - 160,000

Full time

3 days ago

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Benefits offered by this job

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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.