Principal Quality Systems & Design Control Engineer (CRM)

Boston Scientific; Arden Hills (MN); Hybrid; USD 102,000 - 194,000; Full time

Job summary

Boston Scientific in Arden Hills, MN is seeking a Principal Quality Systems Engineer for Cardiac Rhythm Management & Diagnostics. You will lead Design Control awareness and ensure compliance with the Global Quality System and applicable regulatory standards.

The role requires collaboration across Regulatory, Research and Development, Clinical, and Quality teams. You’ll mentor engineers, drive quality improvements, and support audits, all within a hybrid work model.

Qualifications

• Bachelor’s degree in science, engineering, health, or related fields.
• Minimum of 8 years of work experience in the medical device or other regulated industry.
• Solid computer skills including Excel, Word, and PowerPoint.
• Strong communication skills (verbal and written).

Responsibilities

• Deliver and manage completion of CRM divisional deliverables, including updates to procedures, Work Instructions, and knowledge sharing documents
• Active membership of Global Procedural and Design Control Community of Practice
• Drive and provide guidance to team members regarding quality strategies driven by BSC Global Quality System
• Provide project direction, coaching, and mentoring for engineering and technical team personnel
• Work cross-functionally in identifying and resolving procedural issues
• Drive continuous improvement initiatives to enhance CRM Design Control Process and its efficiency while maintaining or improving product quality
• Apply sound, systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving quality issues.
• Advise management on potential improvements or enhancements to quality systems and processes in the company.
• Promote a culture of quality and compliance within the organization through regular communication and training.
• Provide essential support during internal and external audits by presenting Design Control storyboard in front room and addressing questions related to CRM DC process. Provide back room support by supplying necessary documentation and leading DC backroom stream.
• Establish or maintain CRM design control procedures, templates, and tools

Skills

Strong communication skills

Education

Bachelor’s degree in science, engineering, health, or related fields

Tools

Excel

Word

PowerPoint

Job description

Boston Scientific in Arden Hills, MN is seeking a Principal Quality Systems Engineer for Cardiac Rhythm Management & Diagnostics. You will lead Design Control awareness and ensure compliance with the Global Quality System and applicable regulatory standards.

The role requires collaboration across Regulatory, Research and Development, Clinical, and Quality teams. You’ll mentor engineers, drive quality improvements, and support audits, all within a hybrid work model.