Boston Scientific · 15 hours ago
Senior Design Quality Engineer - Interventional Oncology
Maple Grove, MN
Full-time
Hybrid
Mid, Senior Level
$85K/yr - $162K/yr
5+ years expBoston Scientific is a leader in medical science committed to solving critical health industry challenges. The Senior Design Quality Engineer will provide Design Assurance support for New Product Development in the Interventional Oncology business, ensuring product quality and compliance while leading design control and risk management efforts.
Medical DeviceHealthcareHealth CareMedical
No H1B
Responsibilities
Responsible for design control and risk management of next-generation medical devices
Uses clinical knowledge to influence how devices they are working on are tested and designed
Applies sound, systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving quality issues
Independently, or as a member of a team, develops, directs, and executes plans for design control and risk management of complex projects
Leads the implementation and development of product risk management tools (i.e. Hazard Analysis, Fault Tree, FMEAs)
Leads/supports the determination and implementation of Design Controls based on Risk Management, Customer Needs, and Manufacturing Input
Leads the development of and coordinates the execution and documentation of Design Validation and Verification activities
Demonstrates good working knowledge and application of validation and statistical techniques in order to comply with associated regulatory requirements and internal standards
Adds to and promotes the culture of quality-centric patient care and customer satisfaction within the New Product Development team
Promotes and influences compliance to BSC’s quality, business and health & safety systems and market/legal regulations
Provides quality input (SME and/or independent reviewer) as required, at defined project/product/process milestones (e.g., design reviews, project design plans, design/process changes to existing product lines)
Keeps up to date on all ISO/EN/FDA/MDR and other Product Development-related regulatory requirements and relays this information to the Product Development group
Qualification
Required
Minimum of a bachelor's degree in mechanical, electrical, or biomedical engineering (or other related technical discipline)
Self-motivated with a passion for solving problems and a bias for action
5+ years of experience in design assurance, new product development or related medical device / regulated industry experience
Strong communication skills (verbal & written)
Demonstrated use of Quality tools/methodologies
Ability to effectively work and collaborate in a mixed onsite + remote environment
Demonstrated experience creating detailed technical documents
Preferred
Experience working with medical devices industry
ISO 13485, ISO 14971 and Quality System Regulations understanding with a focus on Design Controls and Risk Analysis
Experienced problem solver, capable of facilitating the problem-solving process
Experience with technology acquisition & integration
Experience with design changes, risk management, and corrective action
Benefits
Relocation assistance is available for this position at this time.
Compensation may also include variable compensation from time to time (e.g., any overtime and shift differential) and annual bonus target (subject to plan eligibility and other requirements).
Compensation for exempt, non-sales roles may also include variable compensation, i.e., annual bonus target and long-term incentives (subject to plan eligibility and other requirements).
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
Medical Device Network
2026-02-10
2026-02-09
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