Engineer - Complaints Investigator, Medical Device

Engineer - Complaints Investigator

3 Key Consulting is hiring an Engineer - Complaints Investigator for a consulting engagement with our direct client, a leading global biopharmaceutical company.

The complaints investigation technical investigator will perform the device assessment of complaint samples using equipment such as the CT scanner, SEM material analysis, 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 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 root cause analysis.

S/he will also support the implementation, validation, and operation of the equipment in the CT&I 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.

Top Must-Have Skill Sets:

• Experience in technical investigation and root cause analysis
• Able to collaborate and communicate with cross functional team
• Master's or Bachelor's in Engineering, Science or Biomedical
• 1-2+ years of experience in complaints investigation within a development, manufacturing, post-market or equivalent environment
• Experience in lab environment

Day to Day Responsibilities:

• Perform device assessments of complaints and document results in a report.
• Perform root cause analysis investigations for mechanical and/or electromechanical products.
• Complete evaluation and deliver assessment report on time per Amgen 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 characterization testing and data gathering for investigations.

Red Flags:

No engineering background or experience

Lack of basic qualifications and 3 must have skills

Interview process:

• Phone screening (15-30 min with hiring manager)
• Video call / interview with cross-functional team (3-4 members, 30 min each)

We invite qualified candidates to send your resume to View email address on click.appcast.io. If you decide that you're not interested in pursuing this position, please feel free to look at the other positions on our website You are welcome to also share this opportunity with anyone you think might be interested in applying for this role.