BridgeMed Solutions · 8 hours ago
Entry Level Engineer
Irvine, CA 92618
Full-time
Onsite
New Grad, Entry Level
$23/hr - $26/hr
0+ years expBridgeMed Solutions, Inc is seeking an Entry Level Engineer. The role involves supporting engineering projects related to medical device manufacturing while collaborating with cross-functional teams to ensure compliance with regulatory standards.
Manufacturing
Responsibilities
Support Senior Engineer or projects in the following areas:
Lead and manage engineering projects from concept through to prototype and market release, ensuring alignment with regulatory requirements (FDA, ISO)
Collaborate with cross-functional teams, including engineering, quality assurance, and operations, to develop project plans, schedules, and risk assessments
Develop and review technical documentation, including design specifications, test protocols, and validation reports, to support product development and regulatory submissions
Oversee the execution of validation activities for new and legacy medical devices, ensuring they meet intended performance and safety standards
Facilitate root cause investigations for non-conformance issues, implementing corrective actions and driving continuous improvement initiatives
Project and client management is a must
Qualification
Required
Bachelor's degree in engineering (Biomedical, Mechanical, or related field)
Minimum of 0-1 years of experience in Engineering, medical device industry preferred with a strong understanding of FDA regulations and ISO standards
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
Proficient in Microsoft Office and engineering design software; familiarity with statistical analysis tools (e.g., Minitab), SolidWorks is a plus
Detail-oriented with strong organizational skills, capable of managing multiple projects in a fast-paced environment
Preferred
Experience in medical device manufacturing
Suture Experience is a PLUS!
Benefits
401(k)
401(k) matching
Bonus based on performance
Company parties
Dental insurance
Health insurance
Paid time off
Training & development
Vision insurance
Company
BridgeMed Solutions
We are the leading Contract Manufacturing Organization (CMO) in the transcatheter heart valve area.
51-200 employees
Funding
Current Stage
Growth StageCompany data provided by crunchbase