Product Performance Manager
Saint Paul, MN - USA
Job Summary
JOB DESCRIPTION:
Product Performance Manager
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. Youll also have access to:
- Career development with an international company where you can grow the career of which you dream.
- Employees can qualify for free medical coverage in our Health Investment Plan (HIP) PPO medical plan in the next calendar year.
- 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 bachelors 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 St. Paul MN location in the Electrophysiology Abbotts Electrophysiology (EP) business were 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.
The Product Performance Manager is responsible for leading a team that executes end-to-end complaint management processes including complaint intake product investigations and post-market surveillance activities. This role partners closely with the Quality leadership team and cross-functional stakeholders to ensure a compliant and high-performing complaint handling program that supports patient safety and product quality. The role ensures compliance with global regulatory requirements and internal quality standards while driving continuous improvement in product performance management.
What Youll Work On
- Lead and manage a product performance team responsible for complaint intake evaluation and investigation activities.
- Oversee the complaint management process to ensure timely accurate and compliant handling of customer product complaints.
- Drive high-quality product investigations including root cause analysis corrective actions and risk documentation.
- Ensure compliance with global regulations related to Medical Device Reporting (MDR) vigilance reporting and other OUS applicable reporting.
- Monitor key performance metrics and drive process improvements based on trend analysis.
- Provide input and support for product performance processes including trending signal detection and risk evaluation of product performance data.
- Recognize and identify potential product performance issues and drive timely escalation to the appropriate cross-functional partners to mitigate risk.
- Identify process improvement opportunities and lead initiatives to enhance efficiency compliance and data quality.
- Collaborate cross-functionally with Quality Regulatory Affairs R&D Manufacturing and Clinical teams to resolve product performance issues.
- Support and lead interactions with internal and external auditors ensuring readiness and successful outcomes.
- Ensure high-quality accurate and compliant customer and regulatory communications.
- Ensure proper training development and performance management of team members.
Required Qualifications
- Bachelors degree required.
- Minimum of 5 years experience in the medical device industry.
- Working knowledge with applicable regulatory requirements including ISO 13485 MDD/MDR FDA QSR Health Canada ANVISA TGA NMPA and other international requirements as applicable.
- Experience working in a regulated environment.
- Demonstrated high levels of integrity and professionalism with a proven ability to establish credibility and trust.
- Experience leading and managing teams or serving as a lead to drive issue resolution.
- Demonstrates critical thinking skills with a focus on improving system performance and driving positive outcomes.
- Strong problem-solving skills with proven application of structured problem-solving methodologies and tools.
- Effective technical writing and presentation skills.
- Promotes a high-performance diverse and inclusive culture within a quality focused environment.
Learn more about our health and wellness benefits which provide the security to help you and your family live full lives:
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 on Facebook at and on X @AbbottNews.
The base pay for this position is
$99300.00 $198700.00In specific locations the pay range may vary from the range posted.
JOB FAMILY:
Operations Quality
DIVISION:
EP Electrophysiology
LOCATION:
United States > Minnesota > St. Paul > Tech Center : One St Jude Medical Drive
ADDITIONAL LOCATIONS:
WORK SHIFT:
Standard
TRAVEL:
Yes 5 % of the Time
MEDICAL SURVEILLANCE:
No
SIGNIFICANT WORK ACTIVITIES:
Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day) Continuous standing for prolonged periods (more than 2 consecutive hours in an 8 hour day) Keyboard use (greater or equal to 50% of the workday)Abbott is an Equal Opportunity Employer of Minorities/Women/Individuals with Disabilities/Protected Veterans.
EEO is the Law link - English: EEO is the Law link - Espanol: Experience:
Manager
About Company
WHO WE ARE CREATING LIFE-CHANGING TECHNOLOGY From removing the regular pain of fingersticks as people manage their diabetes to connecting patients to doctors with real-time information monitoring their hearts, from easing chronic pain and movement disorders to testing half the world’s ... View more