Principal Product Complaint Analyst

Boston Scientific • Arden Hills, MN

6d • $102,100 - $194,000 • Hybrid

About The Position

Boston Scientific is seeking a Principal Product Complaint Analyst to lead strategic initiatives that enhance product quality and performance across global markets. The role works with cross-functional teams to address complex challenges using data-driven insights to identify risks, improve processes and support decisions that affect health care worldwide. Patient safety, product quality, regulatory compliance and positive outcomes are central to the position.

The position is hybrid and requires working from the Arden Hills, Minnesota, office at least three days per week. Boston Scientific will not provide employment-visa sponsorship or relocation assistance for this role.

Requirements

• Bachelor's degree, preferably in a scientific, engineering or technical discipline.
• At least 7 years of experience in the medical device, pharmaceutical or diagnostic device industry.
• Proficiency with Microsoft Office applications, including Word, Excel, PowerPoint and Visio.
• Working knowledge and practical application of FDA, ISO and MDR regulations.
• Demonstrated proficiency in project management.

Nice To Haves

• Experience with post-market activities, including complaints and vigilance.
• Corrective and preventive action (CAPA) experience.
• Strong research, communication and presentation skills.
• Effective written and verbal communication, technical writing and editing skills.
• Ability to work independently with minimal direction or supervision.
• Experience with SAS, Snowflake or similar querying and analytics software.

Responsibilities

• Understand and ensure compliance with U.S. and international regulatory requirements for medical device complaint handling and regulatory reporting.
• Participate in the Global Quality Community and lead large, high-impact projects to improve post-market quality across multiple divisions.
• Coordinate parallel tasks and meetings to support collaboration among multisite and cross-functional stakeholders and meet project deliverables and timelines.
• Communicate deliverables, timelines and milestones clearly and succinctly to senior leadership.
• Influence change and align stakeholders to make decisions with limited information.
• Provide audit support.
• Contribute positively to team culture through high-quality work, effective communication, resilience and solution-oriented thinking.
• Use data and analytics to identify risks, opportunities and priorities.
• Support and implement standard operating procedures and work instructions that improve and standardize complaint handling and regulatory reporting processes.
• Apply systems thinking across a complex quality system to streamline processes, identify improvement opportunities and risks, and develop and manage improvement plans.
• Identify and escalate risks, respectfully challenge management and the status quo when appropriate, provide recommendations, and work to resolve issues.
• Work independently across the organization.
• Maintain a primary commitment to patient safety and product quality by complying with the Quality Policy and documented quality processes and procedures.

Benefits

• Core and optional employee benefits are offered; details are available at www.bscbenefitsconnect.com.
• Exempt, non-sales roles may be eligible for an annual bonus target and long-term incentives, subject to plan eligibility and other requirements.

What This Job Offers

• Job Type: Full-time
• Career Level: Principal