Senior Quality Engineer - Electrophysiology - Complaint Investigation Site (CIS)

Additional Location(s): US-MN-Arden Hills; Costa Rica-Coyol; Costa Rica-Heredia

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 This Role:

The Senior Quality Engineer’s primary responsibility is to monitor/trend BSC product performance within the Electrophysiology division, and when appropriate, escalate post-market field performance signals (in collaboration with cross functional teams) to mitigate risk by focusing on patient safety & driving actions to improve product performance. This position will utilize post market data to complete deep dive analysis on Electrophysiology product performance to understand if the products are performing as intended. 

Work mode:

At Boston Scientific, we value collaboration and synergy. This onsite role is based in Arden Hills, MN and requires being on-site at five days per week. We will also consider candidates based in our Costa Rica location.

Relocation assistance:

Relocation assistance is not available for this position at this time. 

Visa sponsorship:

Boston Scientific will not offer sponsorship or take over sponsorship of an employment visa for this position at this time. 

Your Responsibilities may Include:

• Embodying BSC’s Core Values of Caring, Meaningful Innovation, High Performance, Global Collaboration, Diversity, Winning Spirit.
• Analyzing post market surveillance data for patterns and trends and investigating when necessary.  May be responsible for querying & bounding data to support implementation of document releases.
• Responding to Competent Authority requests and/or responsible for compiling post market data collection requests from cross-functional departments.
• Owning/Completing signal evaluation forms to investigate product performance quality signals to determine if products are performing as intended by collaborating with cross-functional team members to complete risk assessment analysis and escalating further when appropriate to help drive actions to improve EP product performance.
• Communicating product performance by formal presentations to management committees and design teams, supporting published product performance reports and customer requests for performance information either directly or through cross-functional departments.
• Providing input for process improvement and helping develop tactical approaches to implement team strategies.
• Perform data analysis for Product Performance and Risk Management documentation by applying statistical methods and software.

• Owns/Leads project activities to ensure continued compliance with evolving BSC post market trending Quality Management System process requirements.
• Open and flexible to change in responsibilities, taking on new engineering tasks and new product lines as the department grows and evolves.
• Fostering a diverse and inclusive workplace that enables all participants to contribute to their full potential in pursuit of organizational objectives.
• May complete and/or approve complaint investigations in accordance with local and global processes.

What we’re looking for in you:

Required Qualifications:

• Minimum of a Bachelor’s degree.
• Minimum of 5 years of related experience in medical device or regulated industry.
• Understanding and a command of highly technical engineering topics and applied statistics.
• Understanding and experience operating within quality system processes and procedures.
• Strong Technical Writing skills.

Preferred Qualifications

• Engineering or Statistical Degree with 5+ years of relevant medical device experience. 
• Strong technical understanding of medical devices & the product interaction with human anatomy.
• Significant participation in the Hazard Analysis and Risk Assessment as related to trend management.
• Experience with the quality system escalations, CAPA investigations and field assessments. 
• Strong experience/understanding of the medical device regulatory requirements of post-market complaint trending and analysis.
• Experience and/or previous collaboration activities with Medical Safety, Design Assurance, Complaint Investigation Site, Supplier Quality and Operations.
• Ability to independently manage project work to define and consistently meet delivery dates.
• Strong communication (verbal and written) and data analysis skills.

Requisition ID: 627377 

Minimum Salary: $ 85000 

Maximum Salary: $ 161500 

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.

Boston Scientific transforms lives through innovative medical technologies that improve the health of patients around the world. As a global medical technology leader for more than 45 years, we advance science for life by providing a broad range of high-performance solutions that address unmet patient needs and reduce the cost of healthcare. Our portfolio of devices and therapies helps physicians diagnose and treat complex cardiovascular, respiratory, digestive, oncological, neurological and urological diseases and conditions. Learn more at www.bostonscientific.com and follow us on LinkedIn.

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.

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.

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