Engineer

Pay range: 35-45/hr

• depending on experience The ideal candidate for this role will have at least 5 years of experience performing complaints handling and failure analysis investigations within a medical device environment, specifically class II or class III devices.

They should be proficient 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 have a background in medical devices, biotech, or biopharma industries and must be local, able to commute onsite 2-3 days per week (ideally residing within Los Angeles, Orange, or Ventura Counties). This role will begin as a one-year contract, with the potential for extension. Engineer

• Complaints Technical Investigator:

  Requires a combination of working remote and going onsite 2 to 3 times per week (average) for complaint returns assessment and/or laboratory equipment setup, development and validation of test methods. Job Description is currently seeking an Engineer
• Complaints Technical Investigator in our Complaints Trending and Investigation group. In support of 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 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.

PREFERRED QUALIFICATIONS

Masters 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 packaged and/or distributed products Understand manufacturing processes for 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