Mechanical Engineer (Medical Device)

BRIDGEMED SOLUTIONS INC

Mechanical Engineer (Medical Device)

Irvine, CA
Full Time
Paid
  • Responsibilities

    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

    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.