Boston Scientific Senior Design Quality Engineer 

Costa Rica 

733688910

Costa Rica-Heredia

Hybrid Roles:

About the role:

This is a hybrid position based out of Heredia, Costa Rica with the expectation to be in the office a minimum of three days per week.

Your responsibilities include:

• Support the execution and documentation of Design Validation & Verification and Usability activities.
• Apply sound, systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving quality issues.
• Work within a cross-functional team to identify and implement effective controls and support product development from concept through commercialization.
• Update and maintain product risk management tools (i.e. Hazard Analysis, Fault Tree, FMEAs).
• Working knowledge of Design Controls. Provide quality and compliance input to project teams for project decisions and deliverables (i.e., Design Change Analysis, Design Inputs, Design Outputs, Test Methods, Design Reviews, Design V&V, Usability Testing, Process Validation and Labeling).
• Lead and support cross-functional root-cause analysis investigation and resolution activities.
• Checks and provides support in the execution and investigation of CAPAs, NCEP, Failure Mode Investigations, etc.
• Reviews and approves operational, test and validation data to establish technical specifications and performance standards for newly designed or modified products and processes.
• Support regulatory submissions to notified bodies.
• Demonstrates a primary commitment to patient safety and product quality by maintaining compliance to the Quality Policy and all other documented quality processes and procedure.

What we’re looking for:

Required Qualifications:

• Bachelor’s degree in mechanical engineering, Biomedical Engineering or related field of study
• 5+ years of experience in design assurance, quality, new product development, or related medical device / regulated industry experience
• Detailed understanding of US and International regulations including 21 CFR, 820, 210, 211, and 11 is required, as well as the Medical Device Directive, EN ISO 13485, and EN ISO 14971.
• High energy problem solver capable of driving items to closure.
• Adaptable and effective collaborator in a team environment and in self-directed work
• Strong communication skills (verbal & written)

Preferred Qualifications

• Demonstrated use of Quality tools/methodologies

Benefits • Life-Work Integration • Community • Career Growth