Principal Quality Engineer

Additional Location(s):  N/A

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:
 
The Principal Quality Engineer will develop, establish, and maintain quality engineering methodologies, systems, and practices which meet BSC, customer, and regulatory requirements.  He/she/they will serve as a Quality representative to improve awareness, visibility, communication on quality initiatives to support departmental, functional, site, divisional and corporate quality goals and priorities.
 
The Principal Quality Engineer will be responsible for leading the Design Assurance activities in the design history file remediation and integration of the Boston Scientific acquisition of the Lumenis laser portfolio. He/she/they will be responsible for working with a cross-functional team to analyze historical product documentation and create a Boston Scientific-compliant product file for future submission and maintenance. He/she/they will build the risk management and usability file and work with R&D, marketing, sales organizations, and other departments, as well as external customers to ensure the integration and remediation are adequate. He/she/they will ensure that information, post-market feedback, and historical documentation are fed back to the R&D and marketing organizations as part of the risk management and design input systems.

Key Responsibilities will include:

• Reviews, creates, and approves DHF documentation, including design inputs, design outputs, risk assessments, verification and validation protocols, and design change documentation.
• Communicates project status and arising challenges through formal presentations to management committees and design teams, supporting cross-functional requests.
• Analyzes customer complaints, events, and other post-marketing surveillance data to build Boston Scientific (BSC) compliant risk management documentation and monitoring methodology.
• Works closely with Regulatory Affairs to support regulatory submissions.
• Provides leadership role on championing cross-functional engineering initiatives on DHF requirements, risk management and best practices.
• Assists in continuous improvement efforts related to DHF management and quality system processes.
• Provides leadership role on championing departmental or cross-functional engineering initiatives.
• Provides project direction, coaching, and mentoring for engineering and technical team personnel.
• Proactively investigates, identifies, and implements best-in-class Quality Engineering practices.
• Mentor for technical guidance for identifying and resolving quality issues.
• Leads in the implementation of assurances, process controls, and CAPA systems designed to meet or exceed internal and external requirements.
• Acts as an effective leader or team member in supporting quality disciplines, decisions, and practices.
• Applies sound, systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving quality issues.
• Assures the development and execution of streamlined business systems which effectively identify and resolve quality issues.

Required Qualifications:

• Minimum of a Bachelors Degree
• Minimum of 7 years of related quality or design assurance experience 
• 10-15% international travel

 

Preferred Qualifications:

• Experience on CFR 820.30 and Risk Management, CAPAs and Usability Files
• Experience with statistical tools (Ex. Mini tab) 
• Working knowledge of IEC13485,60601,62353 and 21CFR820 regulations
• ISO 14971:2019, CFR 820, EU MDR 2017/745, MDD 93/42/EEC
• Must work effectively in a dynamic work environment.
• Strong problem solver with excellent verbal and written communication skills
• Technical background with a passion for continuous improvement
   

Requisition ID: 570819

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 ch