Entry Level Engineer

Bridgemed Solutions Inc.; Irvine (CA); On-site; USD 60,000 - 80,000; Full time

Benefits offered by this job

PTO

Sick days

Holiday Pay

401k

401k Matching

Health-Vision-Dental Coverage

Job summary

BridgeMed Solutions, Inc. in Irvine, CA seeks an Entry Level Engineer to join our medical device manufacturing team. Training will be provided; local candidates in Orange County preferred. 0–1 years of experience in engineering, with FDA/ISO knowledge considered a plus.

The role includes supporting Senior Engineers on projects, ensuring regulatory alignment, and collaborating across engineering, quality assurance, and operations. This is a 100% in-house, full-time position with benefits.

Qualifications

• 0–1 years of engineering experience, medical device preferred.
• Experience with FDA regulations and ISO standards.
• Proven project management experience.
• Strong analytical and problem-solving skills.
• Excellent written and verbal communication.
• Proficiency in Microsoft Office; familiarity with Minitab and SolidWorks.
• Detail-oriented with strong organizational skills.

Responsibilities

• Support Senior Engineer on projects from concept to market release.
• Ensure alignment with FDA and ISO regulatory requirements.
• Perform preventative maintenance and machinery upkeep.
• Collaborate with cross-functional teams to plan schedules and risk assessments.
• Develop and review design specifications, test protocols, and validation reports.
• Oversee validation activities for new and legacy devices.
• Lead root cause investigations and drive corrective actions.
• Manage projects and client communications.

Skills

Project management

Cross-functional collaboration

Analytical thinking

Communication skills

Education

High School Diploma

Biomedical/Mechanical technician courses

Tools

SolidWorks

Minitab

Job description

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.

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

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).
• Preventative maintenance and machinery upkeep.
• 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

• High School Diploma
• Technician courses 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