Boston Scientific · 17 hours ago
Senior Design Assurance Engineer - Electrophysiology
Arden Hills, MN
Full-time
Hybrid
Senior Level
5+ years expBoston Scientific is a leader in medical science with a commitment to solving important health industry challenges. The Senior Design Assurance Engineer will act as the quality/design assurance representative for new product development programs, ensuring design control rigor and robust risk management throughout the product lifecycle.
Health CareMedicalMedical Device
No H1B
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
Own and maintain product risk management documentation (e.g., Risk Management Plan/Report, Hazard Analysis, DFMEA/PFMEA and related analyses as applicable), ensuring alignment with standards and internal procedures
Drive risk-based decision making, including documenting rationale for decisions and prioritization in ambiguous situations
Lead and 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
Lead and 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
Partner cross-functionally with R&D, Project Management, Manufacturing, Regulatory, Clinical, and Marketing to ensure project execution and compliance to design control deliverables
Demonstrate commitment to patient safety and product quality through adherence to quality policy and procedures
Qualification
Required
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
Preferred
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
Benefits
Relocation assistance is available for this position at this time.
Company
Boston Scientific
Boston Scientific is a medical technology company that designs and develops medical devices to diagnose and treat a wide range of condition.
10001+ employees
Funding
Current Stage
Public CompanyTotal Funding
$10.02B2025-02-21Post Ipo Debt· $1.58B
2024-02-22Post Ipo Debt· $2.17B
2022-03-04Post Ipo Debt· $3.28B
Leadership Team
Michael Mahoney
Chairman, President & CEO
Daniel J. Brennan
Chief Financial Officer
Recent News
2026-01-24
2026-01-23
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