BridgeMed Solutions ยท 1 day ago
Engineer (Mechanical - Medical Device)
Irvine, CA
Full-time
Onsite
Mid Level
$33/hr - $43/hr
3+ years expBridgeMed Solutions, Inc is seeking a Manufacturing Engineer to join their dynamic team focused on pioneering medical innovations. The role involves leading engineering projects, collaborating with cross-functional teams, and ensuring compliance with regulatory requirements in the medical device manufacturing process.
Manufacturing
Responsibilities
Experience in medical device manufacturing. - Suture Experience is a PLUS!
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
3+ years of experience in Engineering
Bachelor's or Master's degree in Engineering (Biomedical, Mechanical, or related field)
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
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!
Medical device industry preferred with a strong understanding of FDA regulations and ISO standards
Familiarity with statistical analysis tools (e.g., Minitab) is a plus
Benefits
401(k)
401(k) matching
Company parties
Competitive salary
Dental insurance
Free food & snacks
Health insurance
Opportunity for advancement
Paid time off
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