Complaint Evaluation Engineer

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.

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

This position requires the following skills and attributes:

• Bachelor’s 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

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

• 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