Additional Location(s): N/A
About the role:
As a Principal Product Analyst, you will play a critical role in advancing product quality and patient safety across Boston Scientific's global organization. In addition to leading complaint handling and medical device reporting activities, you will drive large-scale, cross-functional initiatives that strengthen our global post-market quality system. This includes improving complaint handling and regulatory reporting processes, leveraging data analytics to identify risks and opportunities, and supporting continuous improvement initiatives across multiple divisions.
In this highly visible role, you will collaborate with cross-functional and multisite stakeholders, communicate project progress and strategic recommendations to senior leadership, and influence decisions in complex environments. Success in this role requires strong systems-thinking, project management, analytical problem-solving, and communication skills, along with the ability to work independently while fostering a culture of collaboration, accountability and continuous improvement.
Work model, sponsorship, relocation:
At Boston Scientific, we value collaboration and synergy. This role follows a hybrid work model requiring employees to be in our local office at least three days per 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:
• Understand and ensure compliance with U.S. and outside-U.S. regulatory requirements for medical device complaint handling and regulatory reporting.
• Lead large, high-impact projects within the Global Quality Community to improve post-market quality across multiple divisions.
• Coordinate concurrent project activities and facilitate collaboration among multisite, cross-functional stakeholders to achieve project deliverables and timelines.
• Communicate project deliverables, milestones and timelines clearly and effectively to senior leadership.
• Influence change and align stakeholders to drive informed decision-making in situations with limited information.
• Provide audit support during front-room and back-room activities.
• Serve as a positive cultural leader by modeling high-quality work, effective communication, resilience and solution-oriented thinking.
• Utilize data and analytics to identify risks, opportunities and business priorities.
• Support the development and implementation of new standard operating procedures and work instructions to improve and standardize complaint handling and regulatory reporting processes.
• Apply systems-thinking to evaluate complex quality systems, identify process improvements, assess risk and implement sustainable solutions.
• Identify, escalate and help resolve risks while respectfully challenging existing processes and providing recommendations for improvement.
• Work independently across functions and organizational boundaries 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, preferably in a scientific, engineering or technical discipline.
• Minimum of 8 years' experience in the medical device industry.
• Demonstrated ability to adapt to changing priorities while contributing effectively in a dynamic environment.
• Proficiency with Microsoft Office Suite, including Word, Excel, PowerPoint and Visio.
• Working knowledge and practical application of FDA, ISO and MDR regulations within the medical device industry.
• Demonstrated project management experience.
• Ability to travel up to 5% of the time.
Preferred qualifications:
• Experience with nonconformance and corrective and preventive action (CAPA) processes.
• Strong research, communication and presentation skills.
• Excellent written and verbal communication, technical writing and editing skills.
• Demonstrated ability to work independently with minimal direction or supervision.
• Experience with SAS, Snowflake or similar querying and analytics software.
Requisition ID: 632195
Minimum Salary: $ 97000
Maximum Salary: $ 184300
The 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.
