Posted: 04/14/2025 Job Number: 40555

Job Description

Engineer - Complaints Technical Investigator

Top 3 Must Have Skill Sets:

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
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

Red Flags:

Must be local to ATO or willing to relocate immediately.
Must be willing to be on site 2-3 days per week.
Must be familiar with good laboratory practices (GLP)

Summary:

Our company is committed to unlocking the potential of biology for patients suffering from serious illnesses by discovering, developing, manufacturing and delivering innovative human therapeutics. This approach begins by using tools like advanced human genetics to unravel the complexities of disease and understand the fundamentals of human biology.

Our company is currently seeking an Engineer - Complaints Technical Investigator in our Complaints Trending and Investigation group. In support of our mission to serve patients, we are a diverse team working to continuously improve our clinical and commercial drug delivery devices in order to ensure supply and to optimize the patient experience.

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 our 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.

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 our 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.

Basic Qualifications:

Master degree

Bachelor degree and 2 years of experience

Associate degree and 6 years of experience

High school diploma / GED and 8 years of experience

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 our packaged and/or distributed products
Understand manufacturing processes for our 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 range is $31 - $36 per hour with full benefits available, including paid time off, medical/dental/vision/life insurance, 401K, parental leave, and more. Our compensation reflects the cost of labor across several US geographic markets. Pay is based on several factors including market location and may vary depending on job-related knowledge, skills, and experience.

THE PROMISES WE MAKE:

At Crystal Equation, we empower people and advance technology initiatives by building trust. Your recruiter will prep you for the interview, obtain feedback, guide you through any necessary paperwork and provide everything you need for a successful start. We will serve to empower you along the way and provide the path for your professional journey.

For more information regarding our Privacy Policy, please visit crystalequation.com/privacy.

Meet Your Recruiter

Krista McIlwaine

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