Boston Scientific Corporation has flagged the Engineer I, Quality job as unavailable. Let’s keep looking.

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

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 and has been recognized with the Catalyst Award in 2022, a prestigious recognition of diversity, equity and inclusion excellence. Also, we have a Gender Equality Policy to support our commitment.

Hybrid Roles:

Boston Scientific's hybrid workplace includes WFH and onsite. You will have the opportunity to discuss details in the interview. 

About the role:

The Design Assurance Engineer II will have previous experience in data analytics to support all product categories across the Endoscopy portfolio and work with high-performing cross-functional quality systems, post market and sustaining teams to support global complaint and risk threshold management. This position will help lead, communicate, and coordinate complaint reduction and post marketing projects and initiatives. Individual will help develop applications, manage integration of projects with other business processes (supply chain, marketing, etc.) to drive additional ways of utilizing customer feedback (including but not limited to PSUR integration. 

Role focuses on Post Market Surveillance data (complaints, events, reportability, regulatory requests) and helping teams develop applications (example: Power BI) to more easily, accurately, and systematically trend data and compare against other key business indicators; focusing on protecting the design intent of a product to meet safety, efficacy, regulatory, and business requirements. 

The Design Assurance Engineer II will also be responsible for supporting data analysis for the Endoscopy division of Boston Scientific for Post Market Reporting assessments (Periodic Safety Update Reports). The analysis and reporting directly supports product sustainment activities assessing product performance for trends including signal escalation. The role communicates and educates management, R&D, marketing, Design Assurance, plant QA, clinical, and other departments, as well as potentially external customers about complaints monitoring trending and product performance. The role will identify, coordinate, and execute project priorities based on business and department objectives at the BSC Divisional Level. 

Your responsibilities will include: 

  • Actively promote and participate in a cross-functional teamwork environment. 
  • Developing Power BI applications to manage Endoscopy’s Complaint Reduction program, partnering with Urology group as Endo Design Quality Assurance liaison. 
  • Driving complaint reduction projects, project management and roll-out with cross-functional teams. 
  • Lead, communicate, and coordinate complaint reduction and post marketing projects and initiatives. 
  • Scoping, developing and rolling-out applications to support alignment with other key divisional inputs including but not limited to marketing, clinical, regulatory, and quality systems inputs; post market signals focusing on design control and risk management support. 
  • Analyzing customer complaints, compliance events, clinical data, and other post marketing surveillance data by examining the data for patterns and trends and investigating when necessary. 
  • Documenting data reviews, trend analysis, escalations, and actions as an output in formal regulatory submission report (PSUR) for Notified Body review and agreement. 
  • Communicating product performance by formal presentations to management, cross-functional team members, committees and/or design teams, supporting published product performance reports. 
  • Supporting product Post Market activities such assessment of risk based on post market complaint signals and PSUR support for complaint data with intent to focus on application development and integration. 
  • Focusing on continuous improvement by championing and fostering the execution of projects within the local and Global Design Assurance and Post Market organizations to continue to improve process and product performance. 
  • Fostering a diverse and inclusive workplace that enables all participants to contribute to their full potential in pursuit of organizational objectives. 
  • Demonstrating a primary commitment to patient safety and product quality by maintaining compliance to the Quality Policy and all other documented quality processes and procedures. 
  • Providing input for process improvement and helps develops tactical approaches to implement team strategies. 

Required Qualifications 

  • Bachelor’s degree in Biomedical Engineering or related discipline 
  • 2 years of technical experience in the medical device or pharmaceutical industry 
  • Previous experience with Post Market Surveillance activities or equivalent 
  • Demonstrated statistical analysis & data analysis capabilities. 
  • Problem-solving and critical thinking skills 
  • Adept at working in a regulated environment with clinical teams including review of clinical data and analysis of clinical terminology. 
  • Advanced knowledge of Microsoft Excel, Microsoft Powerpoint and Microsoft Word 
  • Proficient with Microsoft Office tools, Teams, and Outlook 
  • Ability to collaborate and influence across multiple, cross-functional teams. 
  • Strong ability to multi-task and be adaptable 

Preferred Qualifications 

  • Experience leading projects, coordinating project priorities based on business and department objectives. 
  • Project management experience with strong presentation and facilitation skills 
  • Experience with Power BI Microsoft Platform 
  • Experience with and/or knowledgeable in Quality System Regulations, Medical Device Regulation, and Quality Standards. 
  • Demonstrated understanding of risk management 

Requisition ID: 577605

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!

Benefits • Life-Work Integration • Community • Career Growth

At Boston Scientific, you will find a collaborative culture driven by a passion for innovation that keeps us connected on the most essential level. With determination, imagination, and a deep caring for human life, we’re solving some of the most important healthcare industry challenges. Together, we’re one global team committed to making a difference in people’s lives around the world. This is a place where you can find a career with meaningful purpose—improving lives through your life’s work.

Read Full Description
Confirmed 5 hours ago. Posted 30+ days ago.

Discover Similar Jobs

Suggested Articles