Entry-Level Medical Device Engineer - Training Included

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

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