Boston Scientific Engineer Sr Quality 

Costa Rica, Alajuela Province, Alajuela 

196532376

Hybrid Roles:

About the role:

This position will be located in Coyol, Costa Rica and will provide close liaison with the BSC Operations team, ensuring appropriate coordination between the Maple Grove, Minnesota design owning team. SE Design Quality Assurance engineer works in close partnership with Operations, Project Management, Regulatory, and Research & Development and focuses on protecting the design intent of a product to meet safety, efficacy, regulatory, and business requirements.

Your responsibilities include:

• Actively promote and participate in a cross-functional teamwork environment.
• Actively participate in the Design Change process to ensure the proposed changes to the products are systemically and thoroughly analyzed and assessed.
• Maintains product risk management documentation (i.e. Hazard Analysis, Fault Tree, FMEAs).
• Supports product Post Market activities such assessment of risk based on post market signals, field assessments, and post market surveillance plans and reports.
• Leads/supports the determination and implementation of Design Controls based on Risk Management, Customer Needs, and Manufacturing Input.
• Leads the development of and coordinate the execution and documentation of Design Validation and Verification activities.
• Applies sound, systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving quality issues.
• Demonstrate good working knowledge and application of validation and statistical techniques to comply with associated regulatory requirements and internal standards.
• Perform regulatory standard assessments and support regulatory submissions to notified bodies.
• Maintain Design History File and Design Input / Output documentation (Product Specification, Component Specifications, and Prints).
• Mentor cross functional team through product development process; specifically, with respect to design control and risk management deliverables

What we’re looking for in you:

Minimum qualifications:

• Bachelor’s degree in an Engineering discipline or related field of study
• 5+ years of experience in design assurance, new product development, or related medical device experience
• Self-motivated with a passion for solving problems and a bias for action
• Hands-on approach to project work and collaboration
• Strong communication skills (verbal & written)
• Demonstrated use of Quality tools/methodologies.
• ISO 13485, ISO 14971 and Quality System Regulations understanding with a focus on Design Controls and Risk Management

Preferred qualifications:

• Previous development and management of complex medical devices
• Previous experience in operations