Sr. Manager - Technical Investigations
Amgen is currently seeking a Sr. Manager in our Complaints Trending and Investigation group. This position will report to our Director of Complaints Trending and Investigation. In support of Amgen's mission to serve patients, the Complaints Trending and Investigation group at Amgen 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 Sr. Manager - Technical Investigations will manage and lead a team of direct reports that conduct technical investigations of Level 2 and 3 complaints associated with product design and/or usability issues, as well as conduct trend and consolidated investigations using data analytics. S/he will be accountable for the validity and integrity of the investigations and reports performed by the team members, including the data and its statistical analysis. S/he will also be accountable for cross functional ideation of design solutions. The Sr. Manager - Technical Investigations maintains close interaction with the engineering and quality management functions to contribute to product improvement and management reporting. Additionally, s/he will be responsible for the management of the investigation lab infrastructure.
- Lead direct reports in the performance of failure analysis of mechanical and/or electromechanical products 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
- Partner with device engineering to develop structured failure analysis processes and tools for current and future device platforms
- Lead direct reports in the performance of technical trend and consolidated investigations. Accountable for validity of statistical assessment of data to identify trends, as well as ownership of monthly reports
- Lead cross functional ideation of design solutions based on output of root cause analysis
- Lead direct reports in the development and performance of relational data analytics in support of investigations
- Owns commitment to deliver reports and investigations on time per Amgen and regulatory requirements
- Ownership of failure investigation procedures and improvements
- 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
- Provide instruction in the proper execution of root cause analysis processes and tools
- Develop and maintain 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
- Point of contact to engineering for communication of potential product improvements
- Provide annual performance evaluations and set performance goals for direct reports
- Provide career guidance, technical coaching and mentoring to direct reports
- Support functional management initiatives and objectives
- Support organizational development and improvement of the quality system
- Up to 10% Domestic and international travel may be required
- Doctorate degree and 2 years of directly related engineering experience; OR
- Master's degree and 6 years of directly related engineering experience; OR
- Bachelor's degree and 8 years of directly related engineering experience; OR
- Associate's degree and 10 years of directly related engineering experience; OR
- High School diploma/GED and 12 years of directly related engineering experience
- Master's Degree or PhD in Engineering, preferred Electrical, Mechanical or BioMed
- 10 or more years of progressive experience as an engineer within the appropriate field of study
- 5 or more years of managerial experience directly managing people and/or experience leading technical teams, projects, programs or directing the allocation of resources
- 5 or more years of experience in complaints or failure analysis investigation within a development or manufacturing environment working with electromechanical Medical Devices, ideally Class II and Class III
- Demonstrated experience with mechanical and/or electromechanical medical devices
- Demonstrated applied 6 Sigma competency, specifically for root cause analysis methodology
- Strong working knowledge of ISO 14971 Risk Management Process (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
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.
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.