Boston Scientific Senior Design Quality Assurance Engineer 

Costa Rica 

273814227

Costa Rica-Heredia

Hybrid Roles:

About the role:

The Neuromodulation Design Quality Assurance Engineer role

Your responsibilities will include:

• Fully motivated to achieve and demonstrate best practices in line with the division’s objectives.
• Apply sound, systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving quality issues.
• Application of Design Control, Risk Management and Post Market Surveillance processes throughout product development lifecycle, independently or as a member of a team. Provide quality and compliance input to colleagues for project decisions and deliverables.
• Creation, execution, and documentation of Design Validation & Design Verification activities such as protocols, test cases, reports, investigation and resolution of issues identified during test.
• Collaborate with cross-functional design team to support the creation and documentation of Risk Management documentation such as Hazard Analysis, Task Analysis, Design Failure Mode and Effects Analysis, and Software Design Failure Mode and Effects and Analysis
• Provides quality input as a subject matter expert and/or independent reviewer. Support internal and external regulatory audits as required.
• Perform quality trending using the complaint and NCEP/CAPA systems. Perform and/or lead risk analyses for CAPA and/or audit findings investigations.
• Actively participate in the Design Change process to ensure the proposed changes to the products are systemically 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.
• Highly cross-functional in nature, this role consults with product experts, design engineering, post market quality, and medical safety functions for risk analysis across the life of Boston Scientific Neuromodulation products.

Required Qualifications:

• Bachelor’s degree in mechanical, electrical, biomedical engineering or equivalent
• 5+ years’ experience in design quality, system test, systems R&D, or product development engineering in medical devices/regulated industry
• Strong communication skills (verbal & written)
• Understanding and demonstrated use of industry standards (e.g. IEC 60601, IEC 62304), within product design and development process
• Strong ability to navigate ambiguous situations in a collaborative, innovative, and people-centric team environment.
• Knowledge of key regulatory requirements including ISO 13485 Quality Management Systems, ISO 14971 Risk Management, 21 CFR 820, and EU MDR.

Preferred Qualifications:

• Experience working with medical electrical equipment and/or active implantable
• Ability to collaborate and work on a highly matrixed and global team
• Variable and Attribute Test method generation and validation experience
• Prior exposure to risk management tools & methodologies such as hazard analysis, FMEA on detailed work with emphasis on accuracy and completeness.