Boston Scientific · 5 hours ago
Senior Design Assurance Engineer
Arden Hills, MN
Full-time
Hybrid
Mid, Senior Level
$85K/yr - $162K/yr
5+ years expBoston Scientific is a leader in medical science committed to solving important health industry challenges. The Senior Design Assurance Engineer will support medical device product development from concept through commercialization, collaborating with various teams to ensure product quality and compliance.
Health CareMedicalMedical Device
No H1B
Responsibilities
Understanding and application of design engineering concepts and tools including Design Failure Modes and Effects Analysis (DFMEA), Design Verification & Validation, Benchmarking, Test Method Validation, and Design Transfer
Apply sound, systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving quality issues including CAPA work
Review and approve quality records, including product specifications, design verification test protocols, and design verification test reports
May lead or contribute to collaborative problem solving of complex technical issues using disciplined, methodical techniques. Tools used include DMAIC, Root Cause Analysis, 5 Whys, Cause & Effect Diagram, and Is-Is Not
Creates, maintains, and enhances cross-functional team partnerships. Provides guidance regarding technical strategies and approaches; works cross-functionally and across multiple sites in identifying and resolving technical issues
Focuses on continuous improvement by championing and fostering the execution of projects within the local and divisional Design Assurance organizations
Fosters a diverse and inclusive workplace that enables all participants to contribute to their full potential in pursuit of organizational objectives
Monitors and ensures compliance with company policies and procedures
Demonstrates a primary commitment to patient safety and product quality by maintaining compliance to the Quality Policy and all other documented quality processes and procedures
Qualification
Required
Bachelors degree in an engineering or related discipline with 5+ years of relevant experience
Experience in Medical Device industry; Knowledgeable in Quality System Regulations, Medical Device Regulation, ISO 14971 and ISO 13485 Quality Standards with a focus on design controls and design optimization
Proficient with Microsoft Office tools including Word, Excel, PowerPoint, and Outlook
Ability to collaborate and influence across multiple, cross-functional teams
Demonstrated technical problem-solving & data analysis capabilities
Preferred
Experience in design engineering or process development, including test method validation, process validation, and continuation engineering
Experience writing specifications, test protocols, and technical reports
Demonstrated use of Quality tools and methodologies including DFMEA, DOE, Brainstorming, Root Cause Analysis, and 5 Why's
Experience in post-market quality, including returned product analysis and corrective and preventative action (CAPA)
Experience with Class III Medical Devices, including Electrical Medical Equipment (EME) or Active Implantable Medical Devices (AIMD)
Adaptable and effective collaborator in a team environment or in self-directed work
Strong ability to successfully multi-task and demonstrate adaptability
Strong communications skills. Effectively present complicated technical information to small and large audiences, from peers to senior leadership, with varying levels of technical expertise
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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