Senior Product Analyst

Boston Scientific; Santa Clarita (CA); On-site; USD 71,500 - 135,800; Full time

Job summary

Boston Scientific is seeking a Senior Product Analyst based in Santa Clarita, California. In this hybrid role, you will analyze customer complaints and collaborate with cross-functional teams to solve complex issues, ensuring compliance with regulatory standards.

The position requires a Bachelor's degree and at least 5 years in the medical device industry. Key responsibilities include managing investigations, ensuring product quality, and helping drive strategic initiatives.

Join us in transforming lives through innovative medical technologies!

Qualifications

• Minimum of 5 years’ experience in the medical device industry.
• Ability to adapt to a dynamic environment.
• Experience supporting corrective and preventive action activities.

Responsibilities

• Analyze customer complaints within the Neuromodulation Division.
• Ensure compliance with regulatory requirements for medical device handling.
• Compose communications detailing investigations and actions.

Skills

Adaptability to changing priorities

Proficiency in Microsoft Office

Knowledge of FDA and ISO regulations

Education

Bachelor’s degree in a scientific or technical discipline

Tools

Microsoft Word

Microsoft Excel

Microsoft PowerPoint

Job description

Additional Location(s): US-MN-Arden Hills; US-CA-Valencia

About the Role

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 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.

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.

Responsibilities

• 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 escale 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.

Compensation

Minimum Salary: $71,500
Maximum Salary: $135,800
The anticipated compensation listed above and the value of core and optional employee benefits offered by Boston Scientific – 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.

Boston Scientific transforms lives through innovative medical technologies that improve the health of patients around the world.

Equal Employment Opportunity

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.

COVID‑19 Vaccination and Substance Testing

Certain U.S. 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. Depending on the position, a prohibited substance test may also be required to comply with safety‑sensitive positions.

Requisition Information

Requisition ID: 630245