Design Assurance Engineer III - Electrophysiology

Boston Scientific • Arden Hills, MN

18h

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 development and execution of design verification and validation strategy; coordinate protocol/report readiness, objective evidence, and traceability closure. 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. Support and, when needed, lead investigations related to NCEP/CAPA, complaints, and failure mode investigations, ensuring containment, root cause, and corrective actions are appropriate and documented. 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)
• 3+ 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

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)
• 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

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 development and execution of design verification and validation strategy; coordinate protocol/report readiness, objective evidence, and traceability closure
• 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
• Support and, when needed, lead investigations related to NCEP/CAPA, complaints, and failure mode investigations, ensuring containment, root cause, and corrective actions are appropriate and documented
• 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