Senior Product Analyst - Defined Term

Senior Product Analyst

At Boston Scientific, we'll give you the opportunity to harness all that's within you by working in teams of diverse and high-performing employees, tackling some of the most important health industry challenges. With access to the latest tools, information and training, we'll help you in advancing your skills and career. Here, you'll be supported in progressing whatever your ambitions.

Everyone at Boston Scientific works toward one goal: transforming lives by addressing the most critical challenges in the medical device industry. Patient care is at the heart of everything we do, and ensuring quality, compliance and positive outcomes is essential to delivering on that commitment.

As a Senior Product Analyst, you will be part of a dynamic team dedicated to enhancing product quality and performance across global markets. In this role, you will analyze customer complaints within the Neuromodulation Division's Complaint Management Center (CMC) and collaborate with cross-functional partners to solve complex challenges. By leveraging data-driven insights, you will identify risks, improve processes and support critical decisions that have a lasting impact on healthcare worldwide. This position offers the opportunity to drive meaningful change while contributing to a team culture built on collaboration, innovation and shared success.

This position is based hybrid. Employees are expected to work from the assigned Boston Scientific facility for a minimum of 3 days a week. Boston Scientific will not offer sponsorship or take over sponsorship of an employment visa for this position at this time. Relocation assistance is not available for this position at this time.

Your responsibilities will include:

• Serve as a positive influence on team culture by modeling high-quality work, effective communication, resilience and solution-oriented thinking.
• Ensure compliance with U.S. and international regulatory requirements for medical device complaint handling and regulatory reporting.
• Review complaint communications and assess regulatory compliance, reportability and potential impact to patient safety and business operations.
• Apply clinical knowledge related to product applications to evaluate identified complaints and conduct investigations by gathering information from clinical staff, field representatives, internal stakeholders and laboratory analyses.
• Establish regulatory reportability decisions using hazard analyses, Design Failure Mode and Effects Analysis (DFMEA), reported event information, investigation findings and regulatory decision models.
• Apply appropriate coding to complaint events to support product performance records and collaborate with engineering, laboratory and other internal teams to review coding and investigation outcomes.
• Compose clear and comprehensive written communications detailing clinical observations, investigations, product analyses and corrective actions, as applicable, for physicians and other end-user customers.
• Support and lead divisional initiatives and strategic priorities.
• Review peer work products and provide constructive feedback while identifying opportunities for process improvement.
• Utilize data and analytics to identify risks, opportunities and business priorities.
• Provide clear, concise communications and presentations to leadership regarding deliverables, timelines and milestones.
• Influence change and align stakeholders to support decision-making in situations with limited information.
• Apply systems-thinking principles to identify process improvement opportunities, mitigate risk and enhance quality system effectiveness.
• Support training activities and knowledge-sharing initiatives across the organization.
• Identify and escalate risks appropriately, respectfully challenge assumptions when necessary and provide recommendations to resolve issues.
• Work independently and collaboratively across functions to achieve business objectives.
• Demonstrate a primary commitment to patient safety and product quality by maintaining compliance with the Quality Policy and all documented quality processes and procedures.

Qualifications:

Required qualifications:

• Bachelor's degree in a scientific, technical or related discipline.
• Minimum of 5 years' experience in the medical device industry.
• Demonstrated ability to adapt to changing priorities and contribute effectively in a dynamic environment.
• Proficiency with Microsoft Office applications, including Word, Excel and PowerPoint.
• Working knowledge and practical application of FDA, ISO and other applicable medical device regulations.

Preferred qualifications:

• Experience supporting corrective and preventive action (CAPA) activities.
• Experience handling complaints for neuromodulation or implantable medical device products.
• Strong research, communication and presentation skills.
• Strong technical writing, editing and documentation skills.
• Ability to work independently with minimal direction or supervision.
• Experience utilizing data analytics to support quality, compliance or business decision-making.
• Proven ability to influence cross-functional stakeholders and drive process improvements.
• Experience presenting recommendations and project updates to leadership audiences.