Biomedical / Electrical / Mechanical Engineer - Medical Device Quality
Location: Irvine, CA
Job Type: Contract with Health and 401k benefits
Duration: 1 year
Schedule: M - F, 8-5
Experience: 2+ years
We are seeking an early-career Biomedical, Electrical, or Mechanical Engineer to support quality and technical investigations for medical devices. This is a hands-on opportunity for an engineer who enjoys troubleshooting products, investigating technical issues, documenting findings, and working with cross-functional teams.
Responsibilities:
- Investigate assigned technical and customer complaints involving medical devices.
- Perform hands-on troubleshooting and evaluation of customer-returned devices and manufacturing nonconformities.
- Document investigation results accurately and in accordance with established procedures and timelines.
- Support manufacturing quality activities, including product/process issues and SAP-related quality functions.
- Assist with complaint intake by reviewing and verifying initial complaint information and coding.
- Monitor and trend customer complaints, service calls, and manufacturing rejections to identify recurring issues.
- Assist with root-cause investigations and corrective actions related to product and process issues.
- Collaborate with Quality, Manufacturing, R&D, Supply Chain, and other teams on product and process improvements.
- Maintain accurate technical and quality documentation.
- Follow applicable company quality procedures and medical-device regulatory requirements.
Qualifications:- Bachelor's degree in Biomedical Engineering, Electrical Engineering, Mechanical Engineering, or a related engineering/science discipline.
- Approximately 2+ years of professional engineering experience.
- Healthcare, medical device, biomedical, biotech, or regulated manufacturing experience is preferred.
- Experience with technical troubleshooting, product evaluation, manufacturing issues, or quality investigations.
- Strong analytical, problem-solving, written, and verbal communication skills.
- Strong computer skills, including Microsoft Excel.
- Ability to review technical information, investigate problems, and clearly document findings.
Preferred:- Experience with medical-device complaints or quality records.
- Familiarity with FDA regulations, ISO 13485, or other medical-device quality requirements.
- Exposure to FDA MDRs, Vigilance reporting, CAPA, nonconformances, or post-market surveillance.
- Experience working with SAP or other ERP/quality systems.
- Experience troubleshooting electrical, mechanical, or electromechanical devices.
Why Consider This Opportunity:- Hands-on engineering experience within a medical-device environment.
- Opportunity to work across engineering, manufacturing, and quality functions.
- Good fit for an engineer looking to build experience in medical-device quality, complaint investigation, and product troubleshooting.