Boston Scientific Design Assurance Engineer II - Electrophysiology 

Costa Rica, Heredia 

611569688

Hybrid Roles:

Your responsibilities will include:

• Responsible for design control and risk management activities.
• Managing and updating product risk management files, specifically Risk Management Plans, Reports, Hazard Analysis, Task Analysis, Design FMEAs
• Collaborating within a team to identify and implement effective controls to support development or maintenance of products to meet internal and external requirements.
• Applying technical skills including sound, systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving quality issues.
• Identifying and driving continuous improvement projects and quality initiatives by partnering and communicating effectively with various functions.
• Planning, organizes and prioritizes own daily work routine to meet established schedule.
• Utilizing standard statistical analysis and problem-solving techniques to determine product acceptance and evaluate process capabilities.
• In all actions, demonstrating a primary commitment to patient safety and product quality by maintaining compliance to the Quality Policy and all other documented quality processes and procedures.
• Coordinates and conducts technical investigation and documentation of non-conforming events and trends using technical investigation plans, eCAPA and BSC Engineering Essentials.
• Other duties as required.

Required qualifications:

• Bachelor’s degree in biomedical engineering, Mechanical, Electrical Engineering or related field of study
• 3+ years related working experience from Medical Device Industry
• Knowledge of ISO 13485, ISO 14971.
• Demonstrated interpersonal skills with ability to work within a team environment
• Strong written/verbal communication skills
• Must be able to work independently under limited supervision

Preferred qualifications:

• Six Sigma problem solving methodologies
• Training experience to FDA regulations, EUMDR or ISO standards