Boston Scientific · 1 day ago
Design Quality Engineer III
US-MA-Marlborough
Full-time
Hybrid
Mid Level
$78K/yr - $149K/yr
3+ years expBoston Scientific is a leader in the health industry, providing opportunities for employees to tackle important challenges. The Design Quality Engineer III will support Design Controls in EP/CRM Integration projects, ensuring product and process safety, quality, and regulatory compliance throughout medical device product development.
Health CareMedicalMedical Device
No H1B
Responsibilities
Apply sound, systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving quality issues
Acts as an effective team member and mentor in supporting quality disciplines, decisions, and practices
Work within a cross-functional team to identify and implement effective controls and support integration of design control related products, records, and processes
Support the verification, validation, and usability testing to meet or exceed internal and external requirements
Develop, update, and maintain Design History File and Design Input / Output documentation (Product Specification, Component Specifications, and Prints)
Generate, update, and maintain product risk management tools (e.g., Hazard Analysis, Fault Tree, FMEAs)
Support Design Assurance (DA) activities as related to Design Control Quality System integration, and other DA related integration priorities
Partner with R&D to determine and implement Design Controls based on Risk Management, Customer Needs, and Manufacturing Input
Partner cross-functionally to identify and support value improvement efforts to support business goals
Qualification
Required
Minimum of a bachelor's degree in mechanical, electrical, or biomedical engineering (or other related technical discipline)
Minimum of 3 years of experience in Quality design assurance, new product development or related medical device/regulated industry experience
Ability to travel up to 10%
Preferred
Quality Integration experience
ISO 13485, ISO 14971 and Quality System Regulations understanding with a focus on Design Controls and Risk Analysis
Boston Scientific experience
Proven ability to influence without authority
Ability to effectively work and collaborate in a mixed onsite + remote environment
Benefits
Core and optional employee benefits offered by Boston Scientific
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
BioWorld Financial Watch
2025-12-25
2025-12-12
Company data provided by crunchbase