Senior Mechanical Engineer for Medical Device Development

2 weeks ago


Irvine, California, United States Bridgemed Solutions Inc Full time
Job Summary

We are seeking a highly skilled Mechanical Engineer to join our team at BridgeMed Solutions Inc. As a key member of our engineering team, you will be responsible for leading and managing engineering projects from concept through to prototype and market release, ensuring alignment with regulatory requirements.

Key Responsibilities

* Lead and manage engineering projects, ensuring alignment with regulatory requirements (FDA, ISO)
* Collaborate with cross-functional teams to develop project plans, schedules, and risk assessments
* Develop and review technical documentation, including design specifications, test protocols, and validation reports
* Oversee the execution of validation activities for new and legacy medical devices
* Facilitate root cause investigations for non-conformance issues and implement corrective actions

Requirements

* Bachelor's or Master's degree in Engineering (Biomedical, Mechanical, or related field)
* Minimum of 3 years of experience in R&D, medical device industry preferred
* Proven experience in project management and cross-functional team collaboration
* Strong analytical skills with the ability to conduct detailed assessments and develop effective solutions
* Excellent communication skills, both written and verbal, with the ability to present complex information clearly to stakeholders

What We Offer

* Competitive salary and benefits package
* Opportunity for advancement and professional development
* Collaborative and dynamic work environment
* ISO and FDA certified company

How to Apply

If you are a motivated and experienced Mechanical Engineer looking for a new challenge, please submit your application, including your resume and cover letter, to us. We look forward to hearing from you.

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