Design Assurance Engineer III - Electrophysiology

at  Boston Scientific Corporation

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
• Knowledge of ISO 62366, ISO 60601

ABOUT THE ROLE

Our team is growing, and we are currently looking for a Design Assurance Engineer III to join our Design Assurance team. This position works closely with New Product Development and Product Life Cycle teams to ensure risk management is applied, adequate design controls are met, and subsequent production and process controls are adequate. This is an intermediate-level Engineering position.

YOUR RESPONSIBILITIES WILL INCLUDE:

• Responsibility 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
• Using clinical knowledge/Data to influence how devices you are working on are tested and designed.
• 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.
• Building quality into all aspects of work by maintaining compliance to all quality requirements.
• 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.
• Other duties as required.