Medical Device Complaint & Failure Analysis Engineer - (JP15808)
Overview
Education
Engineering (PE)
Career level
Senior-level
Remote
Hybrid remote
Compensation
$42-$47/hour
Job Description
Job Title: Medical Device Complaint & Failure Analysis Engineer - (JP15808)Location: Thousand Oaks, CA. 91320 (local candidates only).Employment Type: ContractBusiness Unit: Complaint InvestigationsDuration: 1+ year (with likely extensions and/or conversion to permanent)Posting Date: 09/03/26Pay Rate: $42 - $47/hour W2Notes: Only qualified candidates need apply. Local Role, hybrid onsite to ATO is required 3 times per week (up to 80%).3 Key Consulting is hiring an Medical Device Complaint & Failure Analysis Engineer for a consulting engagement with our direct client, a leading global biopharmaceutical company.Job Description:The ideal candidate for this role will have:
- 5 years of experience performing complaints handling and failure analysis investigations within a medical device environment, specifically class II or class III devices;
- Proficiency with ISO systems, risk analysis processes, and protocol or report writing;
- A bachelor's degree in engineering or sciences such as chemistry, physics, or biology is strongly preferred, though candidates with other educational backgrounds who possess robust laboratory experience will also be considered;
- Experience working in biohazard lab settings is a plus, but not mandatory;
- Excellent written and verbal communication skills, along with strong presentation abilities, are essential as the role involves regular presentations to internal teams.
- Candidates must be local, able to commute onsite 3 days per week, or more if needed (ideally residing within Los Angeles, Orange, or Ventura Counties).
- Experience performing complaints handling and failure analysis investigations within a medical device environment, specifically class II or class III devices
- A bachelor's degree in engineering or sciences such as chemistry, physics, or biology is strongly preferred, though candidates with other educational backgrounds who possess robust laboratory experience will also be considered.
- Excellent written and verbal communication skills
- Lead evaluation of returned products, perform detailed assessments, and document results in a report.
- Complete evaluations and deliver assessment report on time per client 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
- 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.
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FAQs About Medical Device Complaint & Failure Analysis Engineer - (JP15808) Jobs at 3 Key Consulting
What is the work location for this position at 3 Key Consulting?
This job at 3 Key Consulting is located in Thousand Oaks, California, according to the details provided by the employer. Some roles may also include multiple work locations depending on the requirement.
What pay range can candidates expect for this role at 3 Key Consulting?
Candidates can expect a pay range of $42–$47 per hour for this role.
What employment applies to this position at 3 Key Consulting?
The employer has not provided this information. This may be discussed during the hiring process.
What experience level is required for this role at 3 Key Consulting?
3 Key Consulting is looking for a candidate with "Senior-level" experience level.
What education level is required for this job?
The education requirement for this position is Engineering (PE). Candidates with relevant qualifications or equivalent experience may also be considered.
What is the process to apply for this position at 3 Key Consulting?
You can apply for this role at 3 Key Consulting either through Sonara's automated application system, which helps you submit applications 10X faster with minimal effort, or by applying manually using the direct link on the job page.