SolidWorks Mechanical Engineer

Job DescriptionJob DescriptionBridgeMed Solutions, Inc is seeking a Mechanical 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: Mechanical Engineer

Experience: 1-3 of ME Professional Experience required. 1-3 years of Project Coordinating experience . Experience in medical device is a plus. Must have SOLIDWORKS EXPERIENCE

Location: Local candidates only 

Job Type: Full Time, 100% In-House

Salary: $20-$28 DOE (Non-Exempt)

Benefits: PTO, Sick days, Holiday Pay, 401k, Health-Vision-Dental Coverage, Free Lunch Fridays, Professional Development Opportunities

Principal Duties and Responsibilities

• 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 

Skills and Qualifications

• Bachelor's or Master's degree in Engineering (Biomedical, Mechanical, or related field).
• 1-3 of ME Professional Experience required. 
• 1-3 years of Project Coordinating experience . Experience in medical device is a plus. 
• Must have SOLIDWORKS EXPERIENCE
• Proven experience in project coordinating 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
• Detail-oriented with strong organizational skills, capable of managing multiple projects in a fast-paced environment.