Engineer Mechanical Medical Device

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 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.