Engineer

Company: Aditi Consulting
Location: Newbury Park
Posted on: May 6, 2025

Job Description:

Payrate: $ 25.00- $ 27.00/ hr.

The following information provides an overview of the skills, qualities, and qualifications needed for this role.

Summary:
The Engineer - Complaints Technical Investigator conducts forensic evaluations of complaint units for Standard and Advanced complaint investigations associated with product design and/ or usability issues. This role understands customer/ patient use of Company's packaged and/or distributed products, as well as manufacturing processes for these products. Responsibilities also include helping with Root Cause Analysis, investigation lab infrastructure, equipment setup, and method development and validation.

Job Responsibilities:Lead evaluation of returned product, product reserve sample inspections, batch records and review of complaint histories and trends
Provide input to engineering for product improvements
Partner with device engineering to develop structured failure analysis processes and tools for current and future device platforms
Lead root cause analysis to identify the failure mode for Company's products and associated components due to product complaint
Perform failure analysis to identify root cause using processes and tools such as fishbone diagrams, "5 Whys", risk assessments such as FMEA's, Fault Tree Analysis, or tolerance analysis. Additional equipment such as CT scanners, Instron tensile test machines and SEM may be used.
Lead cross functional ideation of design solutions to reduce complaints based on output of root cause analysis, determine feasibility of options through testing and analysis, develop business plans for implementation
Generate final reports in accordance with established procedures, which may include data collection and statistical analysis of the data
Help with investigations lab equipment setup, develop and provide equipment training to personnel, develop and validate test methods, and develop SOPs for equipment use.


Preferred Qualifications:Master's degree in science
5+ years of experience in complaints or failure analysis investigation within a development or manufacturing environment, working with Medical Devices, ideally Class II and Class III
Understand customer / patient use of Company's packaged and/or distributed products
Proven experience with medical devices
Demonstrated Six Sigma proficiency specifically for root cause analysis methodology
Experience with risk management per ISO 14971 (System Risk Analysis, User Risk Analysis, DFMEA/FMEA and other Risk Management tools)
Experience with protocol and report writing, process and test development and execution, and design of experiments
Experience in leading continuous improvement activities by driving the implementation of process and product quality improvement initiatives
Strong technical writing and interpersonal skills


Pay Transparency: The typical base pay for this role across the U.S. is: $ 25.00- $ 27.00/hr. Final offer amounts, within the base pay set forth above, are determined by factors including your relevant skills, education and experience and the benefits package you select. Full-time employees are eligible to select from different benefits packages. Packages may include medical, dental, and vision benefits, 10 paid days off, 401(k) plan participation, commuter benefits and life and disability insurance.

For information about our collection, use, and disclosure of applicant's personal information as well as applicants' rights over their personal information, please see our Privacy Policy (https://www.aditiconsulting.com/privacy-policy).

Aditi Consulting LLC uses AI technology to engage candidates during the sourcing process. AI technology is used to gather data only and does not replace human-based decision making in employment decisions. By applying to this position, you agree to Aditi's use of AI technology including calls from an AI Voice Recruiter.

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Keywords: Aditi Consulting, Lakewood , Engineer, Engineering , Newbury Park, California