Engineer - Complaints Technical Investigator
Posted: 09/03/2026
Job Number: 42734
Job Description
Engineer - Complaints Technical Investigator
Hybrid
Summary
Our company is currently seeking an Engineer - Complaints Technical Investigator in our Complaints Technical Investigations group. In support of our mission to serve patients, the Complaints Technical Investigations group is 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 will perform the device assessment of complaint units using lab equipment such as the CT scanner and Instron testing machines. S/he will be responsible for authoring the assessment report and communicating the findings and results to management and cross-functional team as required. S/he will be responsible for the validity and integrity of the evaluation reports. The Engineer - Complaints Technical Investigator will maintain close interaction with the quality complaints owner. Additional responsibilities include supporting investigations by performing characterization testing, data gathering and analysis, as well as supporting/leading root cause analysis.
S/he will also support the implementation, validation, and operation of the equipment in the lab, providing personnel training on the use of the equipment, developing and updating equipment procedures, participating in the monthly lab safety inspection, and identifying and reporting equipment repairs or maintenance. S/he will work with the vendor to resolve issues and suggest improvements associated with the operation of the equipment.
Responsibilities
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.
Hybrid
Summary
Our company is currently seeking an Engineer - Complaints Technical Investigator in our Complaints Technical Investigations group. In support of our mission to serve patients, the Complaints Technical Investigations group is 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 will perform the device assessment of complaint units using lab equipment such as the CT scanner and Instron testing machines. S/he will be responsible for authoring the assessment report and communicating the findings and results to management and cross-functional team as required. S/he will be responsible for the validity and integrity of the evaluation reports. The Engineer - Complaints Technical Investigator will maintain close interaction with the quality complaints owner. Additional responsibilities include supporting investigations by performing characterization testing, data gathering and analysis, as well as supporting/leading root cause analysis.
S/he will also support the implementation, validation, and operation of the equipment in the lab, providing personnel training on the use of the equipment, developing and updating equipment procedures, participating in the monthly lab safety inspection, and identifying and reporting equipment repairs or maintenance. S/he will work with the vendor to resolve issues and suggest improvements associated with the operation of the equipment.
Responsibilities
- Lead evaluation of returned products, perform detailed assessments, and document results in a report.
- Complete evaluations and deliver assessment report on time per company requirements.
- Support the implementation and management of the lab infrastructure, including all equipment used for investigations
- Provide requirements for lab and investigational equipment to device development teams in support of new device platforms
- Support investigations lab equipment setup, develop and provide equipment training to personnel, develop and validate test methods, and develop SOPs for equipment use.
- Perform root cause analysis investigations for mechanical and/or electromechanical products
- Masters Degree OR
- Bachelor’s degree and 2 years of related medical/biopharma development or Operations experience; OR
- Associate degree and 6 years of related medical/biopharma development or Operations experience.
- 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
- Experience in lab environment
- Excellent written and verbal communication skills, along with strong presentation abilities, are essential as the role involves regular presentations to internal teams.
- Demonstrated Six Sigma proficiency specifically for root cause analysis methodology
- Strong Sense of Responsibility and Time Management.
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.
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