Qureos Mentor

BridgeMed Solutions

<div>Benefits: 
<ul><li>401(k)</li>
<li>401(k) matching</li>
<li>Company parties</li>
<li>Competitive salary</li>
<li>Dental insurance</li>
<li>Free food &amp; snacks</li>
<li>Health insurance</li>
<li>Opportunity for advancement</li>
<li>Paid time off</li>
<li>Vision insurance</li>
</ul> 
BridgeMed Solutions, Inc is seeking a Manufacturing Engineer. Training will be provided. 
 
Are you passionate about pioneering medical innovations? Join our dynamic team at BridgeMed Solutions, where we're revolutionizing healthcare through cutting-edge technology. We are an Irvine-based Contract Manufacturing Organization that is ISO and FDA certified. We are a privately owned company that specializes in tissue heart valve technology. We additionally custom produce transcatheter valves for various clients. Embrace the opportunity to make a meaningful impact on patient care while collaborating with talented professionals in a fast-paced startup environment. Apply now and be part of our journey towards transforming lives. 

 
 
 
Job Title: Manufacturing Engineer 
 
Experience: +3 years of experience in Engineering, experience in medical device is a plus. 
 
Location: Local candidates only (must live in Orange County) 
 
Job Type: Full Time, 100% In-House 
 
Salary: $33-$43 DOE (Non-Exempt) 
 
Benefits: PTO, Sick days, Holiday Pay, 401k, Health-Vision-Dental Coverage, 
 
Principal Duties and Responsibilities 
 
<ul><li>Experience in medical device manufacturing. - Suture Experience is a PLUS!</li>
<li>Lead and manage engineering projects from concept through to prototype and market release, ensuring alignment with regulatory requirements (FDA, ISO).</li>
<li>Collaborate with cross-functional teams, including engineering, quality assurance, and operations, to develop project plans, schedules, and risk assessments.</li>
<li>Develop and review technical documentation, including design specifications, test protocols, and validation reports, to support product development and regulatory submissions.</li>
<li>Oversee the execution of validation activities for new and legacy medical devices, ensuring they meet intended performance and safety standards.</li>
<li>Facilitate root cause investigations for non-conformance issues, implementing corrective actions and driving continuous improvement initiatives.</li>
<li>Project and client management is a must</li>
</ul>Skills and Qualifications 
 
<ul><li>Bachelor's or Master's degree in Engineering (Biomedical, Mechanical, or related field).</li>
<li>Minimum of 3 years of experience in Engineering, medical device industry preferred with a strong understanding of FDA regulations and ISO standards.</li>
<li>Proven experience in project management and cross-functional team collaboration.</li>
<li>Strong analytical skills with the ability to conduct detailed assessments and develop effective solutions.</li>
<li>Excellent communication skills, both written and verbal, with the ability to present complex information clearly to stakeholders.</li>
<li>Proficient in Microsoft Office and engineering design software; familiarity with statistical analysis tools (e.g., Minitab) is a plus.</li>
<li>Detail-oriented with strong organizational skills, capable of managing multiple projects in a fast-paced environment.</li></ul></div>

Engineer (Mechanical - Medical Device)

Join BridgeMed Solutions and explore 1   exciting career opportunities. They're hiring for various roles with options for remote or on-site work. Apply today and become part of their innovative team.

BridgeMed Solutions

ABOUT_COMPANY

Engineer (Mechanical - Medical Device)