11 days old

Engineer - Technical Investigator

Amgen
Thousand Oaks, CA 91360
  • Job Code
    115859361
Amgen

Job ID: R-88748
Location: Thousand Oaks, CA, US 91360

Amgen is currently seeking an Engineer in our Complaints Trending and Investigation group. This position will report to our Sr. Manager of Complaints Trending and Investigation. In support of Amgen's mission to serve patients, the Complaints Trending and Investigation group is 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 - Technical Investigator will support technical investigations of Level 2 and 3 complaints associated with product design and/ or usability issues, and support trend and consolidated investigations using data analytics. Will perform root cause analysis to identify the failure mode for mechanical and/or electromechanical medical devices and associated product components, such as packaging, returned due to product complaint using root cause analysis tools and processes. Additional equipment such as CT scanners, FTIR material analysis and Instron tensile test machines may be used. The Engineer supports trend investigations through the review of manufacturing batch records, evaluation of returned product, product reserve sample inspections, and review of complaint histories and trends. Upon completion of these activities, supports authoring final reports in accordance with established procedures which may include data collection and statistical analysis of the data. The Engineer will own CAPA's identifying design solutions based on root cause and will also support multi-functional ideation of design solutions. Maintains close interaction with the engineering and quality functions to contribute to product improvement.

Responsibilities:
  • Understand customer / patient use of Amgen's packaged and/or distributed mechanical and/or electromechanical products
  • Understand manufacturing processes for Amgen's packaged and/or distributed products
  • Support technical trend and consolidated investigations, including statistical assessment of data to identify trends, as well as generation of monthly reports
  • Support multi-functional ideation of design solutions based on output of root cause analysis
  • Support the development and performance relational data analytics in support of investigations
  • Support failure analysis of mechanical and/or electromechanical product to identify root cause using tools such as tolerance analysis, fishbone diagrams, "5 Whys", and risk assessments such as FMEA's or Fault Tree Analysis
  • CAPA ownership in support of ideation phase
  • Provide guidance to management for trend and failure investigation process improvement
  • Support functional management initiatives and objectives


Basic Qualifications
  • Master's degree; OR
  • Bachelor's degree and 2 years of directly related engineering experience; OR
  • Associate's degree and 6 years of directly related engineering experience; OR
  • High School diploma/GED and 8 years of directly related engineering experience


Preferred Qualifications
  • Degree in Engineering, preferred Mechanical, Electrical, or BioMed
  • 5+years of progressive experience as an engineer within the appropriate field of study
  • 2+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
  • Proven experience with mechanical and/or electromechanical medical devices
  • Demonstrated applied 6 Sigma proficiency, specifically for root cause analysis methodology
  • Knowledge of 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
  • Strong technical writing and interpersonal skills


Amgen 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.

Amgen focuses on areas of high unmet medical need and leverages its expertise to strive for solutions that improve health outcomes and dramatically improve people's lives. A biotechnology pioneer since 1980, Amgen has grown to be one of the world's leading independent biotechnology companies, has reached millions of patients around the world and is developing a pipeline of medicines with breakaway potential.

Join Us

If you're seeking a career where you can truly make a difference in the lives of others, a career where you can work at the absolute forefront of biotechnology with the top minds in the field, you'll find it at Amgen.

Amgen, a biotechnology pioneer, discovers, develops and delivers innovative human therapeutics. Our medicines have helped millions of patients in the fight against cancer, kidney disease, rheumatoid arthritis and other serious illnesses.

As an organization dedicated to improving the quality of life for people around the world, Amgen fosters an inclusive environment of diverse, ethical, committed and highly accomplished people who respect each other but compete intensely to win. Together, we live the Amgen values as we continue advancing science to serve patients.

Amgen is an Equal Opportunity employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status.

PI115859361

<b>Amgen</b><br/><br/><b>Job ID: </b>R-88748<br/><b>Location: </b>Thousand Oaks, CA, US 91360<br/><br/>Amgen is currently seeking an Engineer in our Complaints Trending and Investigation group. This position will report to our Sr. Manager of Complaints Trending and Investigation. In support of Amgen's mission to serve patients, the Complaints Trending and Investigation group is 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.<br><br>The Engineer - Technical Investigator will support technical investigations of Level 2 and 3 complaints associated with product design and/ or usability issues, and support trend and consolidated investigations using data analytics. Will perform root cause analysis to identify the failure mode for mechanical and/or electromechanical medical devices and associated product components, such as packaging, returned due to product complaint using root cause analysis tools and processes. Additional equipment such as CT scanners, FTIR material analysis and Instron tensile test machines may be used. The Engineer supports trend investigations through the review of manufacturing batch records, evaluation of returned product, product reserve sample inspections, and review of complaint histories and trends. Upon completion of these activities, supports authoring final reports in accordance with established procedures which may include data collection and statistical analysis of the data. The Engineer will own CAPA's identifying design solutions based on root cause and will also support multi-functional ideation of design solutions. Maintains close interaction with the engineering and quality functions to contribute to product improvement.<br><br><b>Responsibilities: </b><br><ul><li>Understand customer / patient use of Amgen's packaged and/or distributed mechanical and/or electromechanical products</li><li>Understand manufacturing processes for Amgen's packaged and/or distributed products</li><li>Support technical trend and consolidated investigations, including statistical assessment of data to identify trends, as well as generation of monthly reports</li><li>Support multi-functional ideation of design solutions based on output of root cause analysis</li><li>Support the development and performance relational data analytics in support of investigations</li><li>Support failure analysis of mechanical and/or electromechanical product to identify root cause using tools such as tolerance analysis, fishbone diagrams, "5 Whys", and risk assessments such as FMEA's or Fault Tree Analysis</li><li>CAPA ownership in support of ideation phase</li><li>Provide guidance to management for trend and failure investigation process improvement</li><li>Support functional management initiatives and objectives</li></ul><br><br><b>Basic Qualifications</b><br><ul><li>Master's degree; OR</li><li>Bachelor's degree and 2 years of directly related engineering experience; OR</li><li>Associate's degree and 6 years of directly related engineering experience; OR</li><li>High School diploma/GED and 8 years of directly related engineering experience</li></ul><br><br><b>Preferred Qualifications</b><br><ul><li>Degree in Engineering, preferred Mechanical, Electrical, or BioMed</li><li>5+years of progressive experience as an engineer within the appropriate field of study</li><li>2+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</li><li>Proven experience with mechanical and/or electromechanical medical devices</li><li>Demonstrated applied 6 Sigma proficiency, specifically for root cause analysis methodology</li><li>Knowledge of risk management per ISO 14971 (System Risk Analysis, User Risk Analysis, DFMEA/FMEA and other Risk Management tools)</li><li>Experience with protocol and report writing, process and test development and execution</li><li>Strong technical writing and interpersonal skills</li></ul><br><br>Amgen 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.<br><br>Amgen focuses on areas of high unmet medical need and leverages its expertise to strive for solutions that improve health outcomes and dramatically improve people's lives. A biotechnology pioneer since 1980, Amgen has grown to be one of the world's leading independent biotechnology companies, has reached millions of patients around the world and is developing a pipeline of medicines with breakaway potential.<br><br>Join Us <br> <br> If you're seeking a career where you can truly make a difference in the lives of others, a career where you can work at the absolute forefront of biotechnology with the top minds in the field, you'll find it at Amgen. <br> <br> Amgen, a biotechnology pioneer, discovers, develops and delivers innovative human therapeutics. Our medicines have helped millions of patients in the fight against cancer, kidney disease, rheumatoid arthritis and other serious illnesses. <br> <br> As an organization dedicated to improving the quality of life for people around the world, Amgen fosters an inclusive environment of diverse, ethical, committed and highly accomplished people who respect each other but compete intensely to win. Together, we live the Amgen values as we continue advancing science to serve patients. <br> <br> Amgen is an Equal Opportunity employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status.<br/><br/> <img src="https://analytics.click2apply.net/v/JBGAZkIp58KYTPJVfXzVe"> <p>PI115859361</p>

Categories

Posted: 2019-11-27 Expires: 2019-12-28

Before you go...

Our free job seeker tools include alerts for new jobs, saving your favorites, optimized job matching, and more! Just enter your email below.

Share this job:

Engineer - Technical Investigator

Amgen
Thousand Oaks, CA 91360

Join us to start saving your Favorite Jobs!

Sign In Create Account
Powered ByCareerCast