Engineer

NO RELOCATION CANDIDATES - Local role, hybrid onsite to ATO is required 3 times per week.

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
-Client is currently seeking an Engineer - Complaints Technical Investigator in our Complaints Trending and Investigation group. In support of Client's 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 Client's 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.

JOB 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 Client's 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 OR Bachelor degree and 2 years of experience OR Associate degree and 6 years of experience OR 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 Client's packaged and/or distributed products
Understand manufacturing processes for Client's 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

Client 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.