Design Assurance Engineer III - Electrophysiology

Design Assurance Engineer III - Electrophysiology

Onsite Location(s):
Arden Hills, MN, US, 55112

Additional Location(s): N/A

Diversity - Innovation - Caring - Global Collaboration - Winning Spirit
- High Performance

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.

The Design Assurance Engineer III will serve as the quality/design assurance representative for new product development programs within the Pulse Field Ablation (PFA) catheter portfolio. This role partners closely with R&D, Systems, Clinical, Regulatory, Manufacturing/Operations, and Supplier Quality to ensure design control rigor, robust risk management, and objective evidence supporting safe and effective products from concept through commercialization.

At Boston Scientific, we value collaboration and synergy. This hybrid role is based in Arden Hills, MN and requires being on-site at least three days per week.

Relocation assistance:

Relocation assistance is available for this position at this time.

Boston Scientific will not offer sponsorship or take over sponsorship of an employment visa for this position at this time.

• 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.
• 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.
• 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.

Required qualifications:

• 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.

• Experience supporting electrophysiology and/or cardiac mapping and ablation products or catheter-based therapies (e.g., PFA, RF, cryotherapy).
• Experience creating and…