Abbott

Product Performance Manager

Abbott • $99K — $198K *
St. Paul, MN 55106In-Person
Healthcare
5 - 7 years of experience
Today
Be an Early Applicant
Job Overview by Ladders

Qualifications

  • Bachelor's degree in a related field.
  • 5+ years of experience in the medical device industry.
  • Knowledge of global regulatory requirements including ISO 13485 and FDA QSR.
  • Experience in a regulated environment, ensuring compliance and quality.
  • Proven leadership skills in managing teams and driving issue resolution.
  • Strong critical thinking and problem-solving capabilities.
  • Excellent technical writing and presentation skills.

Responsibilities

  • Lead a product performance team in managing complaint processes.
  • Oversee complaint management to ensure compliance and accuracy.
  • Drive high-quality investigations and root cause analysis.
  • Ensure compliance with global medical device reporting regulations.
  • Monitor performance metrics and implement process improvements.
  • Identify and escalate product performance issues promptly.
  • Collaborate with cross-functional teams to resolve issues effectively.

Benefits

  • Health and wellness benefits for employees and family.
  • Support for work-life balance and personal well-being.
  • Opportunities for career advancement within a diverse environment.
  • Focus on fostering a high-performance and inclusive culture.
Full Job Description
JOB DESCRIPTION:

Product Performance Manager

The Opportunity

This position works out of our St. Paul, MN, location in the Electrophysiology division. In Abbott's Electrophysiology (EP) business, we're 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 You'll 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
  • Bachelor's 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.


Apply Now

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.

The base pay for this position is
$99,300.00 - $198,700.00
In 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)

About Abbott

Abbott Careers

Joining Abbott means becoming part of a globally diverse team dedicated to making a lasting impact on human health. As a leader in healthcare innovation, Abbott provides a dynamic workplace where careers flourish through growth, leadership, and diversity training.

Opportunities at Abbott

Explore a world of opportunities with our team. Whether you're seeking job opportunities in engineering, marketing, research, or healthcare, Abbott offers a variety of positions that allow professionals to grow their careers. Our commitment to diversity and innovation is evident in every aspect of our work, fostering an inclusive culture that values each team member's contribution.

Work You'll Do

At Abbott, every role contributes to our mission of helping people live fuller lives through better health. From groundbreaking research in medical devices to advancements in pharmaceuticals, our team is at the forefront of healthcare innovation. By joining Abbott, you are not just accepting a job; you are embarking on a path of professional and personal growth.

Internship Programs

Kickstart your career with an Abbott internship. Our programs provide invaluable industry experience and a chance to develop essential skills in a real-world setting. Interns at Abbott work on projects that matter, gaining the experience and knowledge necessary to succeed in their future careers.

Professional Development

Abbott is dedicated to the continuous professional development of its employees. With access to cutting-edge technology, leadership programs, and diversity training, our team members are equipped to lead and innovate within the healthcare industry. We support your career journey with robust training programs, mentorship, and opportunities for networking and professional growth.

Benefits and Culture

Our employees enjoy comprehensive benefits designed to support their life and well-being. From health insurance to retirement plans, we ensure our team has everything they need to thrive. Abbott's culture is built on a foundation of respect and integrity, united by a shared commitment to improving health outcomes.

Join Our Team

Discover the impact you can make with a career at Abbott. We are hiring individuals who are passionate, curious, and driven to lead. Search open positions that match your skills and interests on our Jobs page. Prepare your resume, sharpen your interview skills, and get ready to join a team that's at the cutting edge of healthcare solutions.

Stay Connected

Keep up to date with career tips, industry insights, and company news—all from the people who work here. Subscribe to our Careers Blog and personalize your subscription to receive job alerts and insider tips tailored to your preferences.

Explore Abbott

With a commitment to improving life through innovation, leadership, and diversity, Abbott is a place where you can fulfill your potential. See what exciting and rewarding opportunities await at Abbott by exploring our career opportunities today.

SEARCH ABBOTT JOBS

Join us in our mission to make the world a healthier place through innovation, leadership, and diversity. Your journey to a fulfilling career at Abbott starts here.
Learn more about Abbott
Size
113,000 employees
Market Cap
$189 billion
Industry
Healthcare
Net Income
$4.4 billion
Founded
1944
5 Year Trend
+15.6%
Revenue
$34.6 billion
NASDAQ
ABT
* Ladders Estimates

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