Complaint Evaluation Engineer - Applied Medical

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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.

Position Description

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.  

AREAS OF RESPONSIBILITY

As a Complaint Evaluation Engineer, you will evaluate the performance of products returned by the customer.

POSITION DESCRIPTION

• 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

ROOT CAUSE AND DATA ANALYSIS

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

TECHNICAL WRITING

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

TIME MANAGEMENT

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.

PERFORMANCE OBJECTIVES

Within your first 6 months, you will be responsible for learning about our company, contributing to various projects and leading project management initiatives.

During your first 30 days, you will:

• Learn about Applied’s mission and vision and take part in a variety of Applied Learning foundational courses
• Discuss your goals and expectations with your team leaders and read and review all relevant team resources and materials
• Immerse yourself in team meetings and discussions

Within 60 days, you will:

• Exhibit a strong technical understanding of the product lines and projects
• Support team meetings and agendas
• Take on one or more projects that require low to moderate guidance

Within 90 days to 1 year, you will:

• Develop interpersonal connections and relationships with others to effectively accomplish project objectives and deliverables
• Lead moderate to complex projects with minimal guidance or direction
• Demonstrate a strong understanding of Applied’s Quality Management System (QMS) and effectively troubleshoot challenges or obstacles that may affect project timelines
• Handle a variety of projects on your own

INSIDE THIS BUSINESS GROUP

The Complaint Evaluation team is responsible for the investigation of the complaints received for Applied’s devices. The complaint investigation process includes, but is not limited to, testing of the complaint device, performing root cause analysis, and writing a report to document the results of the investigation. A risk analysis may also be performed by utilizing techniques such as Failure Mode and Effect Analyses (FMEAs). Additionally, the Complaint Evaluation team frequently collaborates with other departments to provide continuous feedback for the device.

Position Requirements

This position requires the following skills and attributes:

• 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

Preferred

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

Benefits

The base compensation range for this role is $70000 - $80000 / year for the position in California. Actual compensation packages are based on several factors that are unique to each candidate, including but not limited to skill set, depth of experience, certifications, and specific work location. The range displayed reflects the minimum and maximum target for new hire salaries in California based on the date of this job posting. Your recruiter can share more about the specific salary range compensation package during your hiring process. 

Please understand that the compensation range may be modified in the future. Each amount of pay is considered to be wages or compensation once such amount is earned and determinable. The amount and availability of any bonus, commission, benefit or any other form of compensation may be modified at the Company’s sole discretion, consistent with the law.

The total compensation package for this position may also include [bonuses and/or other applicable incentive compensation plans]. 

Our total reward package also includes the following:

• 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

All compensation and benefits are subject to the requirements and restrictions set forth in the applicable plan documents and any written agreements between the parties.

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.