Entry Level Engineering Technician

BRIDGEMED SOLUTIONS INC; Irvine (CA); On-site; USD 28,000 - 32,000; Full time

Benefits offered by this job

401(k)

401(k) Matching

Bonus based on performance

Company parties

Health insurance

Dental insurance

Paid time off

Training & development

Vision insurance

Job summary

BridgeMed Solutions, Inc, an Irvine-based contract manufacturing organization certified to ISO and FDA standards, is seeking an Entry Level Engineer. Training will be provided to jump-start your career in medical device manufacturing.

Local candidates only (Orange County). You will support the Senior Engineer, lead projects from concept to prototype, ensure regulatory alignment, perform preventative maintenance, and collaborate with cross-functional teams to document validation and design

Qualifications

• High School Diploma is required.
• Technician courses in Biomedical, Mechanical, or related field are desirable.
• 0-1 years experience in Engineering; medical device experience is a plus.
• Strong understanding of FDA regulations and ISO standards; project management experience a plus.

Responsibilities

• 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

Project management

Cross-functional collaboration

Analytical skills

Communication

Education

High School Diploma

Technician courses in engineering

Tools

SolidWorks

Minitab

Microsoft Office

Job 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. 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:

$20-23 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).
• 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 in a fast-paced environment.