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Quality Engineer I-Post Market Design Assurance Job

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Date: Oct 1, 2021

Location: Marlborough, MA, US, 01752

Company: Boston Scientific

Additional Locations:

 

Diversity - Innovation - Caring - Global Collaboration - Winning Spirit - Caring - 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.

 

Engineer I, Post Market Design Assurance 

 

About this role:
Responsible for providing technical acumen and data analysis to the MedSurg divisions of Boston Scientific for Post Market Reporting assessments (Periodic Safety Updates). The analysis and reporting directly supports product sustainment activities assessing product performance for trends including signal escalation. The role identifies, analyzes, helps to investigate, monitors and documents trends at a product performance level for post marketing surveillance data as part of the EU MDR reporting requirements. 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 and at times at the Global BSC level.

 

Responsible for identifying and helping with implementing continuous improvements to improve product performance and the post market support processes. This role provides visibility across site, cross division and with divisional leadership.  
 
Your responsibilities will include:

  • 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.
  • Investigating potential and/or identified trends or data issues with cross-functional teams across the division.  
  • Manage potential actions by updating the Post Market report at appropriate intervals and levels by performing, when necessary, a Health Risk Analysis and/or Risk Management Analysis reviews. 
  • 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.
  • 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.
  • Provides input for process improvement and helps develops tactical approaches to implement team strategies.

 
What we’re looking for in you:
Minimum Qualifications

  • Bachelor’s degree with an Engineering or Science background 
  • Strong communication and presentation skills. Comfort speaking to groups of individuals.  Presentation skills that comfortably and concisely translate performance and issues to peer and senior management audiences.
  • Demonstrated problem-solving & critical thinking 
  • Ability to travel a few times a year
  • Capable working in a regulated environment with clinical teams including review of clinical data and analysis of clinical terminology 
  • Advanced knowledge of Microsoft Excel
  • Proficient with Microsoft Office tools including Word, PowerPoint, Teams and Outlook
  • Ability to collaborate and influence across multiple, cross-functional teams
  • Strong ability to successfully multi-task and adaptability

 
Preferred Qualifications

  • Knowledge of analytical techniques, problem solving, continuous improvement programs, data analytics and statistical analysis
  • Demonstrated statistical analysis & data analysis capabilities
  • Self-starter with the ability to identify improvement opportunities.
  • Experience with and/or knowledgeable in Quality System Regulations, Medical Device Regulation, and Quality Standards.
  • Demonstrated understanding of risk management
  • Familiarity with Post Market requirements and IT systems
  • Experience in working across multiple product areas and cross functionally with DA, R&D and Manufacturing teams
  • Professionalism to represent BSC to external entities
     

 

 

Requisition ID: 503296

 

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 drug-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.

 


Nearest Major Market: Boston

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