Highlights

Our talented associates work with your R&D, Regulatory, Quality, and Manufacturing divisions (or “teams”) to provide cost and time saving strategies, whether it is for simple biocompatibility testing or deep dive consulting on viral inactivation studies for class III medical devices. We not only custom produce the valves from scratch ( tissue to valve), but also fill the gap as in-house consultants offering help in various areas like biocompatibility, ISO 22442, sterilization, viral inactivation qualification, QMS, regulatory submissions and FIH studies.

Description

Benefits:

401(k)
401(k) matching
Bonus based on performance
Company parties
Dental insurance
Health insurance
Paid time off
Training & development
Vision insurance

BridgeMed Solutions, Inc is seeking a Entry Level 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: Entry Level Engineer

Experience: 0-1 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: $23-26 DOE (Non-Exempt)

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

Principal Duties and Responsibilities: support Senior Engineer or projects in the following areas:

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 degree in engineering (Biomedical, Mechanical, or related field).
Minimum of 0-1 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), SolidWorks is a plus.
Detail-oriented with strong organizational skills, capable of managing multiple projects in a fast-paced environment.

Compensation: $23.00 - $26.00 per hour

Lives well bridged - Indeed!

We bridge lives by offering innovative & well thought out solutions to the medical device industry

We are the leading Contract Manufacturing Organization (CMO) in the transcatheter heart valve area. We custom produce Transcatheter Aortic Valve (TAVR), Transcatheter Mitral Valve (TMVR) and Transcatheter Tricuspid Valves as per client requirements based on their IP.

We not only custom produce the valves from scratch ( tissue to valve), but also fill the gap as in-house consultants offering help in various areas like biocompatibility, ISO 22442, sterilization, viral inactivation qualification, QMS, regulatory submissions and FIH studies. Often times working with our partners we can help our clients with stent, delivery system & FIH clinical trials also.

We have the unique talent of manufacturing, consulting, and strategizing services in the area of medical devices, especially transcatheter heart valves. Our specialty is customizing the solutions required based on the device and not recommending the whole “nine yards” for any device, thus saving our clients’ time and resources.

Our talented associates work with your R&D, Regulatory, Quality, and Manufacturing divisions (or “teams”) to provide cost and time saving strategies, whether it is for simple biocompatibility testing or deep dive consulting on viral inactivation studies for class III medical devices. We come with an in-depth knowledge with many years of experience and offer customized solutions to each of our clients on an as needed basis with the utmost integrity.

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