Boston Scientific · 3 hours ago
Design Assurance Engineer III - Electrophysiology
Cambridge, MA
Full-time
Hybrid
Mid Level
$82K/yr - $156K/yr
4+ years expBoston Scientific is a leader in medical science committed to solving important health industry challenges. The Design Assurance Engineer III will support new product development and sustaining activities for cardiac mapping and ablation systems, ensuring safety, quality, and compliance of products.
Health CareMedicalMedical Device
No H1B
Responsibilities
Work cross-functionally with R&D, project management, manufacturing, regulatory, clinical and marketing to ensure project success
Leads/supports the determination and implementation of Design Controls based on Risk Management, Customer Needs, and Manufacturing Input
Maintains product risk management documentation (i.e. Hazard Analysis & FMEAs)
Leads/supports the development of and coordinates the execution and documentation of Design Validation and Verification activities
Applies sound, systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving quality issues
Supports and leads the execution and investigation of CAPAs, NCEP, Complaints, Failure Mode Investigations, etc
Demonstrate good working knowledge and application of validation and statistical techniques to comply with associated regulatory requirements and internal standards
Able to navigate gray space by applying risk-based criteria to prioritize project work
Support cross functional team through product life cycle process; specifically, with respect to design control and risk management deliverables
Qualification
Required
Minimum of a bachelor's degree in Materials, Mechanical, Electrical, Chemical, Biotechnology, Electromechanical or related field of study
Minimum 4 years of experience in Quality Assurance and/or Design Assurance, Sustaining, R&D, Manufacturing or related medical device experience
ISO 13485, ISO 14971, and Quality System Regulations understanding with a focus on Design Controls and Risk Analysis
Experience navigating design, manufacturing and/or supplier variations
Preferred
Strong understanding of NCEP/CAPA processes
Previous experience working to create/maintain risk documentation such as FMEAs and HAs
Experience working with Stature or FMEA MED-8 software
Self-motivated with a passion for solving problems and a bias for action
Ability to manage multiple priorities and work with ambiguity
Strong communication skills (verbal & written)
Proficiency in collaborating with interdisciplinary teams
Familiar with EP environment
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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