Planet Pharma
https://cdn.haleymarketing.com/templates/63514/logos/square.png
https://www.propharmagroup.com
https://www.propharmagroup.com
true
Engineer - Complaints Technical Investigator
Posted: 04/16/2025
2025-04-16
2025-05-20
Employment Type:
Contract
Job Category: Engineering
Job Number: 619095
Is job remote?: Hybrid
Country: United States
Job Description
Target PR Range: 30-40/hr
*Depending on experience
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
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.
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 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.
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 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
*Depending on experience
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
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.
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 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.
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 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
Share This Job:
Related Jobs:
Login to save this search and get notified of similar positions.About Thousand Oaks, CA
Ready to take your career to the next level in the vibrant city of Thousand Oaks, California? Nestled in the heart of Ventura County, this bustling city offers a perfect blend of suburban charm and urban amenities. With a strong job market, top-notch schools, and breathtaking views of the Santa Monica Mountains, Thousand Oaks is an ideal location for professionals seeking growth and fulfillment. Explore job opportunities near iconic sites like the Gardens of the World, catch a show at the Fred Kavli Theatre, or indulge in the local culinary scene featuring dishes from around the world. Join this dynamic community and unlock your potential in Thousand Oaks! Start your job search now to find your perfect fit in this captivating city.
Although this hasn't been an issue at Planet Pharma, the staffing industry has seen an increase in people falsely representing themselves as recruiters to gather personal information from job seekers. For your safety, do not provide sensitive data to anyone you have not spoken with thoroughly and never provide banking information during the application process. Candidate safety is a top priority at Planet Pharma.
