Boston Scientific · 23 hours ago
Design Assurance Engineer III
Maple Grove, MN
Full-time
Hybrid
Mid Level
$78K/yr - $149K/yr
3+ years expBoston Scientific is a leader in medical science, dedicated to transforming lives through innovative medical solutions. They are seeking a Design Assurance Engineer III to support WATCHMAN projects within the Cardiology division, responsible for ensuring the safety, quality, and compliance of medical device products throughout their development and commercialization phases.
Health CareMedicalMedical Device
No H1B
Responsibilities
Support the verification, validation, and usability planning and testing to meet or exceed internal and external requirements
Develop, update, and maintain Design History File and work with R&D for Design Input / Output documentation (Product Specification, Component Specifications, and Prints)
Work within a cross-functional team to identify and implement effective controls and support product development through commercialization
Support regulatory submissions to notified bodies
Develop, update, and maintain product risk management tools (i.e. Hazard Analysis, Fault Tree, FMEAs)
Develop, update, and maintain the usability file: plan, participate in usability assessments, and generate/update usability documentation
Actively participate in the Design Change process for systems to ensure the proposed changes to the products are systemically and thoroughly analyzed and assessed through the Design Control process
Apply systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving quality issues, with guidance/collaboration of the team
Qualification
Required
Minimum of a Bachelors Degree in Science or Engineering, or equivalent
Minimum of 3 years of experience in design assurance, quality, product development or related medical device or regulated industry experience
Self-motivated with a passion for solving problems and a bias for action
ISO 13485, ISO 14971, and Quality System Regulations understanding
Strong communication skills (verbal & written) and presentation skills
Preferred
Focus on detailed work with emphasis on accuracy and completeness
Excellent organizational and planning skills; drives for results
High energy problem solver capable of driving items to closure
Ability to collaborate and work on a global team with peers in R&D, Process Development, Manufacturing and other groups
Benefits
Relocation assistance may be 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
$10.01B2025-02-21Post Ipo Debt· $1.57B
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
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2026-02-05
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