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, we are committed to solving the challenges that matter most – united by a deep caring for human life. Our mission to advance science for life is about transforming lives through innovative medical solutions that improve patient lives, create value for our customers, and support our employees and the communities in which we operate. Now more than ever, we have a responsibility to apply those values to everything we do – as a global business and as a global corporate citizen.

So, choosing a career with Boston Scientific (NYSE: BSX) isn’t just business, it’s personal. And if you’re a natural problem-solver with the imagination, determination, and spirit to make a meaningful difference to people worldwide, we encourage you to apply and look forward to connecting with you!

At Boston Scientific, we recognize that nurturing a diverse and inclusive workplace helps us be more innovative and it is important in our work of advancing science for life and improving patient health. That is why we stand for inclusion, equality, and opportunity for all. By embracing the richness of our unique backgrounds and perspectives, we create a better, more rewarding place for our employees to work and reflect the patients, customers, and communities we serve. Boston Scientific is proud to be an equal opportunity and affirmative action employer.

Boston Scientific maintains a prohibited substance free workplace. Pursuant to Va. Code § 2.2-4312 (2000), Boston Scientific is providing notification that the unlawful manufacture, sale, distribution, dispensation, possession, or use of a controlled substance or marijuana is prohibited in the workplace and that violations will result in disciplinary action up to and including termination.

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.