Complaint Evaluation Engineer

Complaint Evaluation Engineer in Rancho Santa Margarita, California | Careers at Applied Medical Skip to Main Content Please Enable Cookies to Continue Please enable cookies in your browser to experience all the personalized features of this site, including the ability to apply for a position. WELCOME PAGE Returning Candidate? Log back in!

Complaint Evaluation Engineer

Position Location US-CA-Rancho Santa Margarita

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Applied Medical is a rapidly growing, global organization that develops, manufactures and distributes medical devices to more than 75 countries. Our driving purpose is to satisfy the three fundamental healthcare needs: enhanced clinical outcomes, outstanding value and unrestricted choice. For 30 years, Applied Medical has been at the forefront of innovation and technology. As a result of our highly vertically integrated business model, we control all of our processes in-house, from R&D concept to clinical implementation. Applied Medical engineers take a hands-on approach, utilizing in-house cutting-edge technologies, such as automation and robotics, advanced metal processing, injection molding, and rapid prototyping. We invest heavily in R&D, advanced technologies and most importantly the growth of our team members.

Applied Medical is proud to have a culture firmly grounded in teamwork, collaboration and regulatory compliance, while providing opportunities for growth and choice in individual career paths.

Position Description

As a Complaint Evaluation Engineer , you will be responsible for working within the framework of a team and performing the following activities:

• Evaluate the performance of products returned by the customer
• Perform device analysis in accordance with model-specific procedures and protocols
• Perform root cause analysis to investigate alleged product deficiencies
• Propose corrective/preventive actions as required
• Compose detailed reports describing results from investigations
• Complete evaluations in a timely and accurate manner

Position Requirements

This position requires the following skills and attributes:

• Bachelors degree in Mechanical Engineering, Biomedical Engineering, Electrical Engineering or similar engineering discipline
• Minimum of 1 year of experience in the medical device field or other regulated industry
• Effective problem solving and troubleshooting skills
• Proficient computer skills, including knowledge of spreadsheets and word processing
• Possess excellent oral and written communication skills
• Able to work independently, in a team environment and cross-functionally with other departments
• Able to learn quickly and be self-motivated
• Strong multitasking and prioritization skills
• Ability to respond to the urgent needs of the team with a proven track record of meeting deadlines

Preferred

The following skills and attributes are preferred, but are not required:

• Experience in conducting failure investigations, reliability testing and/or performing failure analysis leading to root cause and corrective/preventive actions
• Working knowledge of FDA and ISO regulations
• Working knowledge of manufacturing processes and equipment

Benefits

• Training and mentorship with ongoing learning and development courses
• On-campus wellness activities
• Comprehensive medical and dental and vision coverage
• Education reimbursement program
• 401(k) program with discretionary employer match
• Generous vacation accrual and paid holiday schedule

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Applied Medical is an Equal Opportunity Employer

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