Product Performance Analyst II

Working at Abbott

At Abbott, you can do work that matters, grow, and learn, care for yourself and family, be your true self and live a full life. Youâll also have access to:

• Career development with an international company where you can grow the career you dream of.
• Free medical coverage for employees* via the Health Investment Plan (HIP) PPO
• An excellent retirement savings plan with high employer contribution
• Tuition reimbursement, the Freedom 2 Save student debt program and FreeU education benefit - an affordable and convenient path to getting a bachelorâs degree.
• A company recognized as a great place to work in dozens of countries around the world and named one of the most admired companies in the world by Fortune.
• A company that is recognized as one of the best big companies to work for as well as a best place to work for diversity, working mothers, female executives, and scientists.

The Opportunity

This position works out of our Tech Center in St. Paul, MN in the EP division.

In Abbottâs Electrophysiology (EP) business, weâre advancing the treatment of heart disease through breakthrough medical technologies in atrial fibrillation, allowing people to restore their health and get on with their lives.

As the Product Performance Analyst II, you'll have the chance to perform two different functions. The first consists of managing product experience investigations and all activities pertaining to product experiences for Abbott. This includes, but is not limited to: receiving and investigating reports of worldwide product experiences/events on a variety of products, entering information into the complaint database, independently determining and filing appropriate medical device regulatory reports with various regulatory agencies to worldwide governing bodies in addition to the FDA, participating in cross-functional projects, facilitating investigation findings of product issues, assist with internal and external audits, and providing comprehensive reports, analysis, and insights on product experiences, and may extract data from the complaint database to various teams (e.g. Regulatory, Quality Engineering). 

The other role of the Product Performance Analyst II is to perform evaluations of returned products, coordinating product testing/analysis with other departments and external consultants, preparing technical reports of findings, operating and maintaining the Product Performance Laboratory and equipment, and collecting and evaluating analysis data and entering it into the complaint database. 

The Product Performance Analyst II may assist in the trending of complaint data as requested by management, including preparation of trending charts utilizing the complaint database and other programs, in support of the department. 

What Youâll Work On

• Initiates and manages the product experience file. Maintains accurate entry of product experiences in the database. Triages new product experience report files from time to time. 
• Investigates events in a timely manner. Uses procedures, judgment, and experience to determine appropriate testing of returned products with occasional support; can ascertain when additional support is needed from other teams based on product analysis findings (e.g. potential manufacturing-related issues). Maintains accurate entry of product experiences in database.   Records condition of returned products including observations and photographs. Interprets technical product specifications, Device History Records, or measurements obtained; and always utilizes safe biohazard and chemical handling practices.
• Communicates verbally and in writing both internally and externally regarding information needed specific to product experiences (e.g. physicians, hospital personnel, sales representatives, international offices).  Maintains positive and cooperative communications and collaboration with all levels of employees, customers, contractors, and vendors. 
• Independently assesses the product experience to determine if a medical device report needs to be filed with various global regulatory agencies (e.g., FDA, European Competent Authorities) and sends reports within required timeframes, consulting as needed with management.
• Independently assesses the complaint to determine if an escalation is required. May participate in cross-functional product experience review groups on a regular basis or as requested (e.g. cross-functional product experience teams, new product teams, risk management meetings). 
• Ensures accurate department procedures and work instructions are maintained.  Supports inspections by regulatory agencies (e.g. FDA, TUV, BSI, etc.) as requested.  Provides support to the Legal Department regarding product complaints. 
• Works collaboratively with cross-functional groups (e.g. QEs, R&D) on evaluation trends or findings. May coordinate product testing/analysis with other departments and external consultants.  
• May track returned products within the database, as appropriate. 
• Train new employees to the product experience handling process.
• May collaborate on or support new product launches and integration.
• Supports the Quality Management Systems (QMS), Environmental Management Systems (EMS), and other regulatory requirements.  Complies with U.S. Food and Drug Administration (FDA) regulations, other regulatory requirements, Company policies, operating procedures, processes, and task assignments.  
• Collaborate independently with other team members and departments needing product experience information;  be able to conduct evaluations with customers or field staff with minimal direction, utilizing experience and knowledge of products and various types of product complaints;  be able to make sound decisions regarding medical device reporting to various global regulatory agencies, minimizing the need for input from department management.
• May develop QDR slides and deep dives for monthly QDR review, analyzes trends, speaks to anomalies and provides recommendations.
• Supports complaint database upgrades and conversions by providing input and performing system testing.
• Knowledgeable with multiple product families and could be considered the Subject Matter Expert for product experience management. 
• May cross-functionally lead Quality System process improvements which  include training, corrective action and preventive action (CAPA) activities, product and process planning, supporting audits, and validation.
• Performs other related duties and responsibilities, on occasion, as assigned.
• Work environment varies from well lighted office/cubicle, low to moderate noise level, to a variety of conditions caused by travel requirements such as customer offices, research labs, hospitals, hotels, use of automobiles, commercial travel, weather, etc. 
• Performs tasks that regularly require good correctable vision and hand/eye coordination. Activities also require significant use of voice and hearing for discussions with other employees. 

Required Qualifications

• Four-year degree, preferably in the healthcare, science, or technical fields; or 2-year degree and 10 years of relevant experience supporting complaint handling investigations, medical device reporting, product evaluation, or related work

• Knowledge of global regulations for medical device reporting and medical terminology is a plus

• Strong written and oral communication skills are required.

• Candidate must be able to work well independently and on teams in a busy department while managing multiple ongoing tasks and investigations simultaneously

• Good problem-solving and proficient computer skills are required

• Experience working in a broader enterprise/cross-division business unit model preferred.

• Ability to work in a highly matrixed and geographically diverse business environment.

• Ability to work within a team and as an individual contributor in a fast-paced, changing environment.

• Ability to leverage and/or engage others to accomplish projects.

• Strong verbal and written communications with ability to effectively communicate at multiple levels in the organization.

• Multitasks, prioritizes and meets deadlines in timely manner.

• Strong organizational and follow-up skills, as well as attention to detail.

• Ability to travel approximately 10%, including internationally.

• Ability to maintain regular and predictable attendance.

Apply Now

* Participants who complete a short wellness assessment qualify for FREE coverage in our HIP PPO medical plan. Free coverage applies in the next calendar year.

Learn more about our health and wellness benefits, which provide the security to help you and your family live full lives:  www.abbottbenefits.com

Follow your career aspirations to Abbott for diverse opportunities with a company that can help you build your future and live your best life. Abbott is an Equal Opportunity Employer, committed to employee diversity.

Connect with us at www.abbott.com, on Facebook at www.facebook.com/Abbott and on Twitter @AbbottNews and @AbbottGlobal.

The base pay for this position is $57,300.00 â $114,700.00. In specific locations, the pay range may vary from the range posted.