Job Description

Job Description

Job Description

BridgeMed 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: +3 years of experience in research and development, experience in medical device is a plus. 

Location: Local candidates only (must live in Orange County)

Job Type: Full Time, 100% In-House

Salary: $25-$40 DOE (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).
• Minimum of 3 years of experience in R&D, 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) is a plus.
• Detail-oriented with strong organizational skills, capable of managing multiple projects in a fast-paced environment.

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