Complaint Evaluation Engineer at Applied Medical Europe B.V.

Rancho Santa Margarita, California, United States -

Full Time

Start Date

Immediate

Expiry Date

26 Aug, 26

Salary

0.0

Posted On

28 May, 26

Experience

0 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Root Cause Analysis, Failure Analysis, Medical Device Investigation, Technical Documentation, Mechanical Testing, Functional Testing, Problem Solving, Critical Thinking, ISO 13485, FDA Regulations, Medical Device Reporting, Laboratory Testing, Technical Writing, Cross-functional Collaboration, Biohazard Handling, Quality Management Systems

Industry

Medical Equipment Manufacturing

Description

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 to a larger capacity than is possible in typical positions. Position Description Position Overview: The Complaint Evaluation Engineer plays a critical role in Applied Medical’s post-market quality and patient safety efforts by investigating returned medical devices and evaluating real-world product performance. This hands-on, laboratory-based engineering role focuses on device teardown, functional and mechanical testing, and recreation of reported product issues to determine root cause and support continuous improvement. Working closely with cross-functional engineering and quality teams, the complaint evaluation engineer contributes to regulatory compliance, technical documentation, and post-market surveillance activities in alignment with Food and Drug Administration standards, International Organization for Standardization (ISO) 13485 requirements, and Medical Device Reporting expectations. This position is well-suited for engineering professionals seeking experience in medical device investigation, failure analysis, and post-market quality engineering. Key Responsibilities Perform complaint evaluations and investigations by conducting visual, mechanical, and functional assessments of returned medical devices to evaluate real-world product performance. Execute root cause analysis activities by disassembling devices, recreating reported issues, and applying structured problem-solving methodologies to identify underlying causes. Conduct hands-on laboratory testing and troubleshooting using test fixtures, measurement tools, and simulated clinical-use conditions to validate investigative findings. Prepare technical documentation and reports that clearly summarize test methods, results, conclusions, and recommendations in accordance with FDA, ISO 13485, and Medical Device Reporting requirements. Collaborate cross-functionally with research and development, manufacturing, quality, and clinical development teams to communicate findings and support post-market regulatory activities. Support continuous improvement initiatives by contributing to enhancements in test methods, investigative processes, and documentation practices. Participate in training and professional development to apply feedback constructively and strengthen technical and analytical capabilities. Success in This Role Looks Like Delivering accurate and thorough investigations that identify root cause and support patient safety and product quality. Producing clear, compliant technical reports that meet post-market regulatory and quality system expectations. Effectively collaborating with cross-functional engineering teams to communicate findings and escalate product concerns. Consistently applying structured problem-solving approaches to complex medical device performance issues. Contributing to process improvements that enhance complaint evaluation efficiency, consistency, and technical rigor. Success in This Role Looks Like: Delivering accurate and thorough investigations that identify root cause and support patient safety and product quality. Producing clear, compliant technical reports that meet post-market regulatory and quality system expectations. Effectively collaborating with cross-functional engineering teams to communicate findings and escalate product concerns. Consistently applying structured problem-solving approaches to complex medical device performance issues. Contributing to process improvements that enhance complaint evaluation efficiency, consistency, and technical rigor. Position Requirements The following skills and attributes are required: Work onsite in a highly collaborative engineering and laboratory environment Bachelor’s degree in Mechanical Engineering, Biomedical Engineering, Electrical Engineering, or a related field Minimum of one year of experience in a regulated industry, such as medical device, pharmaceutical, laboratory, aerospace, or strong internship and lab experience Demonstrate strong problem-solving abilities, critical thinking, and a root-cause-focused mindset Ability to take and apply feedback constructively Effective written and verbal communication skills Proficient with spreadsheets, word processing, and technical documentation tools Strong organizational skills and the ability to manage multiple investigations simultaneously Comfortable performing hands-on testing, troubleshooting, and mechanical/electrical evaluation of devices Comfortable handling, inspecting, and testing returned medical devices that have been used in clinical and surgical environments, in accordance with safety and biohazard handling procedures Preferred The following skills and attributes are preferred: Experience with failure analysis, complaint investigations, or reliability testing in a regulated environment. Familiarity with post-market regulatory systems, including Medical Device Reporting, corrective and preventive action processes, and quality management system requirements. Understanding of laboratory testing protocols and test equipment used in mechanical or electrical evaluation. Comfortable handling, inspecting, and testing returned medical devices that have been used in clinical and surgical environments, in accordance with safety and biohazard handling procedures. Experience working in an FDA-regulated or ISO 13485-certified organization. Technical writing experience, including preparation of engineering reports or regulatory documentation. Strong analytical capability with an ability to understand integrated mechanical and electrical systems. Benefits Competitive compensation range: $71000 - $80000 / 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.

Responsibilities

The Complaint Evaluation Engineer investigates returned medical devices through teardowns and mechanical testing to determine root causes of product issues. They prepare technical reports and collaborate with cross-functional teams to ensure regulatory compliance and support continuous product improvement.