Boston Scientific · 3 hours ago
Design Assurance Engineer II
Maple Grove, MN
Full-time
Hybrid
Entry, Mid Level
$72K/yr - $136K/yr
2+ years expBoston Scientific is a leader in medical science committed to solving important health industry challenges. They are seeking a Design Assurance Engineer II to contribute to the development and sustainability of high-risk percutaneous coronary intervention systems, ensuring product safety and compliance throughout the product lifecycle.
Health CareMedicalMedical Device
No H1B
Responsibilities
Drive and document Design Verification, Validation, and Usability activities that ensure products perform as intended in real‑world use
Apply structured, data‑driven problem‑solving methodologies to identify, communicate, and resolve quality issues
Partner with cross‑functional teams to embed effective design controls and support development from concept through commercialization
Develop, update, and maintain Design History Files (DHF), including Design Inputs, Outputs, and product specifications
Lead and maintain risk management artifacts such as Hazard Analyses, Fault Trees, and FMEAs
Lead or support root‑cause investigations and corrective actions with cross‑functional stakeholders
Evaluate, develop, and validate test and inspection methods to ensure robust design performance
Champion patient safety and product quality by ensuring compliance with quality systems, procedures, and regulatory requirements
Support regulatory submissions and interactions with notified bodies
Qualification
Required
Minimum of a Bachelor's degree in Engineering or a related technical discipline
Minimum of 2 years of experience in Design Assurance, Quality, R&D, or New Product Development within medical devices or another regulated industry
Strong analytical and problem‑solving skills, with the ability to guide teams through structured investigations
Ability to work effectively in a matrixed, geographically diverse organization
Hands‑on experience using quality tools and methodologies
Preferred
Working knowledge of FDA regulations, GMP, and ISO 13485
Advanced computer skills, including statistical analysis, data interpretation, and technical reporting
Project leadership experience, with the ability to influence cross‑functional teams and drive timely, high‑quality outcomes
Effective collaborator who thrives in both team‑based and self‑directed environments
Clear, confident communicator (written and verbal)
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
WBJournal.com
2026-02-07
2026-02-07
Company data provided by crunchbase