About this opportunity
Boston Scientific lists this Senior Product Analyst - Defined Term opportunity in arden hills, Minnesota. Review the employer’s description below for duties, qualifications and application requirements.
Job description
Locations
US-CA-Valencia; US-MN-Arden Hills
Position Type
This role is a 12 Month Defined Term Position.
Overview
As a Senior Product Analyst, you will join a dynamic US‑based team dedicated to enhancing product quality and performance across global markets. Your primary focus will be analyzing customer complaints within the Neuromodulation Division’s Complaint Management Center, collaborating with cross‑functional partners to solve complex challenges, and driving continuous improvement that impacts patient care worldwide.
Responsibilities
Model high‑quality work, effective communication, resilience, and solution‑oriented thinking within the team culture.
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, 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 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 elevate 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.
Boston Scientific Corporation is an equal opportunity employer. All employment decisions are made without regard to race, religion, color, national origin, citizenship, sex, sexual orientation, gender identity, gender expression, veteran status, age or disability.
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Who can apply
Review the original listing for work authorization, qualifications and employer requirements.