Senior Design Assurance Engineer - Electrophysiology

Boston Scientific • Arden Hills, MN

8h

About The Position

Your responsibilities will include: Support implementation of design controls appropriate to program risk and phase; plan and execute phase-appropriate design assurance deliverables. Develop, review, and maintain Design History File (DHF) content including design inputs/outputs, traceability, and design review evidence. Provide design assurance subject matter guidance and independent review at defined milestones and design reviews. Support usability/human factors activities as applicable, including inputs to use-related risk analysis, validation readiness, and documentation. Apply validation and statistical techniques to ensure methods and acceptance criteria meet regulatory expectations and internal standards. Ensure design changes, supplier/manufacturing variations, and risk impacts are assessed and documented within the design control framework.

Requirements

• Bachelor's degree in Engineering or related technical discipline (Mechanical, Biomedical, Electrical, Materials, Chemical, or similar)
• 5+ years of experience in Design Assurance, Quality Assurance, R&D, Manufacturing Engineering, or related work in medical devices or other regulated industries
• Working knowledge and demonstrated application of design controls and risk management best practices
• Working knowledge of ISO 13485, ISO 14971, and applicable Quality System Regulations (FDA QSR or equivalent)
• Proven ability to operate effectively in cross-functional teams and communicate clearly in written and verbal formats
• Experience supporting design verification and validation method development, including test method validation and use of statistical techniques
• Demonstrated strength in structured problem solving and leading cross-functional investigations

Nice To Haves

• Experience supporting electrophysiology and/or cardiac mapping and ablation products or catheter-based therapies (e.g., PFA, RF, cryotherapy)
• Experience creating and maintaining risk documentation (e.g., FMEAs, hazard analyses) and using risk management tools (e.g., Stature, FMEA-MED or similar)

Responsibilities

• Support implementation of design controls appropriate to program risk and phase
• Plan and execute phase-appropriate design assurance deliverables
• Develop, review, and maintain Design History File (DHF) content including design inputs/outputs, traceability, and design review evidence
• Provide design assurance subject matter guidance and independent review at defined milestones and design reviews
• Support usability/human factors activities as applicable, including inputs to use-related risk analysis, validation readiness, and documentation
• Apply validation and statistical techniques to ensure methods and acceptance criteria meet regulatory expectations and internal standards
• Ensure design changes, supplier/manufacturing variations, and risk impacts are assessed and documented within the design control framework

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Number of Employees: 5,001-10,000 employees