Sr. Product Analyst - Cardiac Diagnostics

Additional Location(s): US-MN-Arden Hills; US-MN-Mankato/Rochester; US-MN-Maple Grove

Diversity - Innovation - Caring - Global Collaboration - Winning Spirit - High Performance

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.

 

About the role:
Boston Scientific’s Cardiac Monitoring Center is seeking a Senior Product Analyst who will be responsible for capturing, handling, analyzing, and driving proactive initiatives with the customer feedback and requests in alignment with the Services Quality System and the Cardiac Diagnostic business. The role coordinates activities with internal, field, and end use customers.  Responsible for adherence to Good Manufacturing Practices (GMPs), the Code of Federal Register (CFR) and all other governmental regulations.  Communicates investigation results via reports and written communications, as appropriate. Boston Scientific Cardiac Diagnostics Services is maturing its systems and processes for delivering a model for efficiently and compliantly processing customer feedback and requests. This role contributes significantly to this maturation. The management approach for the role is based on a cross functional team centered model where each employee has a voice in how we operate and optimize current processes.  This position is in a supportive environment of providing employees with opportunities to learn and enhance skill sets that are aligned with future career direction and the growth of the business. 

 

Your responsibilities will Include: 

• Review customer feedback and requests and then assess for regulatory compliance, reportability, and potential impact to patient safety and business operations.
• Apply clinical knowledge, as related to product application, to evaluate identified customer feedback and requests.  Investigate by gathering sufficient data from clinical staff, field representatives, internal employees, and laboratory analysis.
• Establish regulatory reportability decisions using event investigation and regulatory decision models
• Participate in development and modification of decision models with changes in product advances/therapies to uphold consistent compliance 
• Apply codes to events to facilitate product performance records.  Review coding and investigations with engineering, laboratory, and other internal staff.
• Support communications and reports detailing the clinical observation, investigation and/or product analysis, and corrective actions, as applicable, to physician and other end use customers
• Identify trends and drive applicable actions to reduce future complaints
• Represent the Monitoring Center in the development and sustainment of a robust feedback, communication and complaint handling system
• Provide document controls support (Windchill updates, routing, approvals, etc.) for the Monitoring Center

 

Required qualifications: 

• Minimum of a bachelor’s degree
• Minimum of 5 years of experience
• Hands-on experience in medical device complaint handling
• Familiarity with medical device terminology as well as anatomical and physiological terminology

 

Preferred qualifications:

• Master’s degree with 3+ years of experience
• Previous complaint handling experience with Boston Scientific and or Cardiac Diagnostics Services devices and services
• Experience with Boston Scientific documentation control system (Windchill)
• Previous experience with audit support activities
• Excellent written and verbal communication skills
• Strong proficiency in common computer applications such as Microsoft Office (Excel, Word, Outlook); experience with presentation applications such as PowerPoint and/or database applications such as Microsoft Access, and complaint database applications such as GCMS.
• Must be self-motivated, goal-driven and results-oriented; must be able to perform with limited guidance and direction
• Positive attitude with the ability to work with others in a team environment
   

Requisition ID: 580227

Among other requirements, Boston Scientific maintains specific prohibited substance testing requirements for safety-sensitive positions.  This role is deemed safety-sensitive and, as such, candidates will be subject to a drug test as a pre-employment requirement.  The goal of the drug testing is to increase workplace safety in compliance with the applicable law.  

As a leader in medical science for more than 40 years,