Complaint Evaluation Engineer

Overview

Applied Medical is a new generation medical device company with a proven business model and commitment to innovation fueled by rapid business growth and expansion. Our company has been developing and manufacturing advanced surgical technologies for over 35 years and has earned a strong reputation for excellence in the healthcare field. Our unique business model, combined with our dedication to delivering the highest quality products, enables team members to contribute in a larger capacity than is possible in typical positions.

Collaboration is a fundamental part of our organization's culture and is essential to our continued success. As such, the successful candidate for this position is expected to work on-site, enabling them to engage fully with colleagues and contribute to cross-functional initiatives. Therefore, the ability to work collaboratively and contribute to a positive and supportive team environment is a key requirement for this role.

As a Complaint Evaluation Engineer
, you will 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

The job requires conducting thorough investigations and analyses to identify the underlying causes of failures and identifying trends in the complaint data.

This role will ensure the accuracy, clarity, and compliance of our documentation, reports, and technical materials related to our products and processes.

The job entails efficiently prioritizing and organizing tasks to meet deadlines, effectively managing time constraints, and swiftly addressing urgent matters to ensure timely completion of critical assignments.

• Bachelor’s degree in Mechanical Engineering, Biomedical Engineering, Electrical Engineering or a similar engineering discipline.
• Minimum of one 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.
• Work independently, in a team environment and cross-functionally with other departments.
• Learn quickly and be self-motivated.
• Strong multitasking and prioritization skills.

The following skills and attributes are preferred:

• Experience in conducting failure investigations, reliability testing and performing failure analysis leading to root cause and corrective/preventive actions.
• Working knowledge of Food and Drug Administration (FDA) and International Organization for Standardization (ISO) regulations.
• Working knowledge of manufacturing processes and equipment.

• Competitive compensation range: $70,000 - $80,000 / year (California).
• Comprehensive benefits package.
• Training and mentorship opportunities.
• On-campus wellness activities.
• Education reimbursement program.
• 401(k) program with discretionary employer match.
• Generous vacation accrual and paid holiday schedule.

Please note that the compensation range may be adjusted in the future, and bonus and incentive compensation plans may apply.

Our total reward package reflects our commitment to employee growth and well-being, as we invest in your development and offer a range of benefits designed to enhance your career and life.

All compensation and benefits are subject to plan documents and written agreements.

Equal Opportunity Employer

Applied Medical is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to age, ancestry, color, disability (mental and physical), exercising the right to family care and medical leave, gender, gender expression, gender identity, genetic information, marital status, medical condition, military or veteran status, national origin, political affiliation, race, religious creed, sex (including pregnancy, childbirth, breastfeeding and related medical conditions), or sexual orientation, or any other status protected by federal, state or local laws in the locations where Applied Medical operates.