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BridgeMed Solutions · 2 months ago

Engineer (Mechanical - Medical Device)

Irvine, CA 92618

Full-time

Onsite

Mid Level

$33/hr - $43/hr

3+ years exp

BridgeMed Solutions, Inc is seeking a Manufacturing Engineer to join their team. The role involves leading engineering projects for medical device manufacturing while ensuring compliance with regulatory standards and collaborating with cross-functional teams.

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

Medical device manufacturingFDA regulationsISO standardsEngineering design softwareProject managementAnalytical skillsCommunication skillsOrganizational skillsCross-functional collaboration

Required

Bachelor's or Master's degree in Engineering (Biomedical, Mechanical, or related field)

Minimum of 3 years of experience in Engineering

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