Sr. Engineer, Complaints/Product Analysis

 

At West, we’re a dedicated team that is connected by a purpose to improve patient lives that has been at the center of our Company for more than a century. Our story began when Herman O. West solved the problem of supplying penicillin in mass quantities to the US Government during World War 2. Through our work to deliver thousands of life-saving and life-enhancing injectable medicines to millions of patients daily, West’s indelible mark on the healthcare industry has just begun. A name started our story. How will yours help write our future?  

 

There’s no better place to join an inclusive community of professionals with opportunities for lifelong learning, growth and development. Supported by benefit programs, we empower the physical, mental, emotional and financial health of our team members and their families.  

 

We believe in giving back to help those in need in the communities where we live and work. And are equally committed to creating a healthier environment and planet through our sustainability efforts.  

 

Job Summary:

 

In this role, you will work under the direction of the Product Analysis Manager to support activities related to product root-cause failure investigations on electro-mechanical drug delivery devices and other related products.   You will additionally drive lean initiatives on the investigation process, manage communication with internal and external customers, and train team members on new devices.

 

Essential Duties and Responsibilities:

 

• Utilizes on the job experience, critical thinking skills, and root cause analysis methodologies to assist lab technicians with atypical and/or complex root cause determination.
• Independently performs investigations to determine root cause for customer received complaints pertaining to issues beyond device functionality; including but not limited to manufacturing, shipping and receiving, production environment, and labeling.
• Is proficient in the use and maintenance of laboratory test equipment necessary for conducting root-cause investigations, such as Instron, CT scanner, oscilloscope, power supply, multi-meter, microscopes.
• Is proficient in the process of conducting root cause investigations.
• Has effective technical writing skills and is able to communicate findings in a technical, concise, and effective manner with little to no assistance.  Documents investigation reports per procedures.

• Assists the Product Analysis Manager with:

• Review and approval of other technician’s investigation reports
• Training technicians on the investigation processes and use of laboratory equipment.
• Performing daily, weekly, and/or monthly tracking and trending activities related to complaints and other lab metrics.
• New customer onboarding
• Complaint-handling process improvements / lean initiatives.

• Communicates investigation results to customers and aids in management of customer relationships.
• Contributes to the design and development of new tests and debugging methods.
• Identifies critical product issues. Assists with Issue Reviews and Corrective & Preventive Actions (CAPAs) when necessary. Contacts appropriate support and/or management to ensure issues are reported and resolved.
• Creates and maintains a clean, neat, and safe work environment through identifying and resolving potential safety hazards.
• Facilitates teamwork and collaboration between departments to maximize processes and resolve problems.
• Demonstrates a “Customer Service” approach to all activities and assignments.
• Conforms with and abides by all regulations, policies, work procedures, instruction, and all safety rules.
• Complies with the company’s safety and quality policies at all times, including proper handling of biohazard materials and components.

• Exhibits regular, reliable, punctual and predictable attendance.

 

Basic Qualifications: 

 

• Education: Minimum of Bachelor's in Science or Engineer