Senior Product Complaint Analyst

Boston Scientific Corporation; Santa Clarita (CA); Hybrid; USD 72,000 - 136,000; Full time

Job summary

Boston Scientific Corporation is seeking a Senior Product Analyst to enhance product quality and performance globally. The role analyzes neuromodulation complaints, collaborates with cross-functional partners, and uses data-driven insights to drive improvements in safety and effectiveness.

The position emphasizes regulatory compliance, detailed investigations, and impactful written communications to physicians and stakeholders, with a hybrid work model based in the U.S. facilities.

Qualifications

• Bachelor’s degree in a scientific, technical or related discipline.
• Minimum 5 years’ experience in the medical device industry.
• Strong knowledge of FDA, ISO and other applicable medical device regulations.
• Proven ability to analyze complaints, investigations and regulatory reporting.

Responsibilities

• Review complaint communications and assess regulatory compliance and reportability.
• Apply clinical knowledge to evaluate identified complaints and conduct investigations.
• Establish regulatory reportability decisions using hazard analyses and DFMEA.
• Code complaints accurately and collaborate with engineering and labs on outcomes.
• Prepare clear written communications for physicians and end users.
• Use data analytics to identify risks and inform leadership decisions.

Skills

Regulatory compliance

Data analytics

Technical writing

Communication skills

Presentation skills

Microsoft Office

FDA/ISO regulations

Process improvement

Education

Bachelor’s degree in a scientific, technical or related discipline

Tools

Microsoft Office

Job description

Additional Location(s): US-CA-Valencia; US-MN-Arden HillsDiversity - Innovation - Caring - Global Collaboration - Winning Spirit - High PerformanceAt 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.About the role:Boston Scientific was recognized as a Glassdoor Best Place to Work in 2026, ranking No. 15 on the Top 100 list, reflecting the culture our employees experience every day.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.Work model, sponsorship, relocation: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.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.Requisition ID: 637091Minimum Salary: $ 71500Maximum Salary: $ 135800The anticipated compensation listed above and the value of core and optional employee benefits offered by Boston Scientific (BSC) – see www.bscbenefitsconnect.com—will vary based on actual location of the position and other pertinent factors considered in determining actual compensation for the role. Compensation will be commensurate with demonstrable level of experience and training, pertinent education including licensure and certifications, among other relevant business or organizational needs. At BSC, it is not typical for an individual to be hired near the bottom or top of the anticipated salary range listed above.Compensation for non-exempt (hourly), non-sales roles may also include variable compensation from time to time (e.g., any overtime and shift differential) and annual bonus target (subject to plan eligibility and other requirements).Compensation for exempt, non-sales roles may also include variable compensation, i.e., annual bonus target and long-term incentives (subject to plan eligibility and other requirements).For MA positions: It is unlawful to require or administer a lie detector test for employment. Violators are subject to criminal penalties and civil liability.Boston Scientific transforms lives through innovative medical technologies that improve the health of patients around the world. As a global medical technology leader for more than 45 years, we advance science for life by providing a broad range of high-performance solutions that address unmet patient needs and reduce the cost of healthcare. Our portfolio of devices and therapies helps physicians diagnose and treat complex cardiovascular, respiratory, digestive, oncological, neurological and urological diseases and conditions. Learn more at www.bostonscientific.com and follow us on LinkedIn.Boston Scientific Corporation has been and will continue to be an equal opportunity employer. To ensure full implementation of its equal employment policy, the Company will continue to take steps to assure that recruitment, hiring, assignment, promotion, compensation, and all other personnel decisions are made and administered without regard to race, religion, color, national origin, citizenship, sex, sexual orientation, gender identity, gender expression, veteran status, age, mental or physical disability, genetic information or any other protected class.Please be advised that certain US based positions, including without limitation field sales and service positions that call on hospitals and/or health care centers, require acceptable proof of COVID-19 vaccination status. Candidates will be notified during the interview and selection process if the role(s) for which they have applied require proof of vaccination as a condition of employment. Boston Scientific continues to evaluate its policies and protocols regarding the COVID-19 vaccine and will comply with all applicable state and federal law and healthcare credentialing requirements. As employees of the Company, you will be expected to meet the ongoing requirements for your roles, including any new requirements, should the Company’s policies or protocols change with regard to COVID-19 vaccination.Among other requirements, Boston Scientific maintains specific prohibited substance test requirements for safety-sensitive positions. This role is deemed safety-sensitive and, as such, candidates will be subject to a prohibited substance test as a requirement. The goal of the prohibited substance testing is to increase workplace safety in compliance with the applicable law.