Design Quality Assurance Engineer I

Boston Scientific - Maple Grove, MN

Full-time - Entry Level

Maple Grove, MN

Miscellaneous Manufacturing

About the position

The Design Assurance Engineer I is a quality engineer role that supports medical device product development throughout the product life cycle, from concept to commercialization. This position involves working with a high-performance cross-functional team to ensure the safety, quality, and compliance of launched products, particularly in the Interventional Oncology and Vascular franchises. The role is based in Maple Grove, MN, and focuses on continuous improvement of commercial value for medical devices.

Responsibilities

• Apply sound, systematic problem-solving methodologies to resolve quality issues
• Act as an effective team member in supporting quality disciplines, decisions, and practices
• Work within a cross-functional team to identify and implement effective controls and support product development from concept through commercialization
• Monitor field performance of recently launched and established medical devices against risk assessments
• Support Post Market activities such as assessment of risk based on post market signals, field assessments
• Actively participate in the Design Change process to ensure the proposed changes to the products are systematically and thoroughly analyzed and assessed
• Demonstrate good working knowledge and application of validation and statistical techniques in compliance with associated regulatory requirements and internal standards
• 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 and Usability tools (e.g., Hazard Analysis, Fault Tree, FMEAs, Task Analysis)
• 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

Requirements

• Bachelor's degree in an engineering related discipline
• Self-motivated with a passion for solving problems and a bias for action
• Strong communication skills (verbal & written)
• Demonstrated use of Quality tools/methodologies
• Ability to travel up to 20% (Domestic and International)

Nice-to-haves

• Degree in Biomedical, Chemical, or Mechanical Engineering
• Medical Device industry experience
• ISO 13485, ISO 14971 and FDA Quality System Regulations understanding with a focus on Design Controls and Risk Analysis
• Knowledge of design changes, complaint reduction, and corrective action
• Adaptable and effective contributor in a collaborative team environment or in self-directed work

Benefits

• Competitive salary
• Access to the latest tools, information, and training
• Support for career advancement
• Diverse and inclusive workplace culture