BridgeMed Solutions, Inc is seeking a Manufacturing 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: Manufacturing Engineer

Experience: +3 years of experience in Engineering, experience in medical device is a plus.

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

Job Type: Full Time, 100% In-House

Salary: $33-$43 DOE (Non-Exempt)

Benefits: PTO, Sick days, Holiday Pay, 401k, Health-Vision-Dental Coverage,

Principal Duties and 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

Skills and Qualifications

* Bachelor's or Master's degree in Engineering (Biomedical, Mechanical, or related field). * Minimum of 3 years of experience in Engineering, 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.