Principal Quality Systems Engineer - Global Risk Management & Design Activities

Principal Quality Systems Engineer – Global Risk Management & Design Activities

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.

We are seeking a Principal Quality Systems Engineer – Global Risk Management & Design Activities to join the Global Quality Systems organization. In this enterprise leadership role, you will serve as a global subject matter expert for Design Controls and Risk Management processes, with a focus on capital equipment and complex systems. You will lead strategic initiatives that strengthen the Global Quality System, support Project Guardian and other enterprise transformation efforts, and ensure compliance with Boston Scientific quality standards and global regulatory requirements.

The incumbent will be working closely with Global Quality System stewards, Design teams and cross-functional stakeholders, you will establish and govern global processes, drive standardization and continuous improvement, and lead Global Communities of Practice (CoPs) that advance risk management excellence across the product lifecycle. This role offers the opportunity to influence quality strategy, improve product development processes and strengthen patient safety through enterprise-wide collaboration.

This role follows a hybrid work model requiring employees to be in their assigned local office at least three days per week. This position may be based in our Arbor Lakes, Arden Hills or Maple Grove, Minnesota;
Marlborough, Massachusetts; or Spencer, Indiana. Boston Scientific will not offer sponsorship or take over sponsorship of an employment visa for this position at this time. Relocation assistance is not available for this position at this time.

Your responsibilities will include:

• Serve as the global subject matter expert for Design Controls and Risk Management processes, with an emphasis on capital equipment and complex systems.
• Develop, govern and continuously improve Global Risk Management procedures, methodologies and best practices that support compliant product development and lifecycle management.
• Partner with Global Quality System stewards, Design teams and cross-functional stakeholders to ensure consistent implementation and continuous improvement of Global Risk Management and Design Activities processes.
• Lead Global Communities of Practice to promote collaboration, knowledge sharing, process harmonization and adoption of enterprise best practices.
• Analyze trends identified through Quality System audits, regulatory submissions, Quality Management Review (QMR) metrics and other performance indicators to identify opportunities for process improvements and enhanced compliance.
• Partner with upstream and downstream process owners to maintain effective integration between Global Risk Management, Design Activities and related Global Quality System processes, including Production and Process Controls, Material Controls and Post Market Surveillance.
• Support Project Guardian initiatives by providing technical leadership, process expertise and implementation support for Design Controls and Risk Management activities.
• Support internal audits, external audits and regulatory inspections by providing documentation, audit responses and subject matter expertise.
• Lead Global Corrective and Preventive Action (CAPA) activities, including complex, cross-functional and multi-site investigations that drive sustainable quality system improvements.
• Apply advanced problem-solving methodologies and quality engineering principles to identify, prioritize and resolve complex quality system issues.
• Drive enterprise continuous improvement initiatives that simplify business processes, improve operational effectiveness and support VIP objectives.

Required qualifications:

• Minimum Bachelor's degree in Engineering, Science, Health Sciences or another related discipline.
• Minimum of 7 years'…