Boston Scientific NEURO Principal Design Quality Assurance Engineer HEREDIA 

Costa Rica 

959834674

Costa Rica-Heredia

Hybrid Roles:

About the role

This is a role for someone ready to step into increased technical ownership, cross-functional influence, and strategic collaboration. In partnership with the Design Quality Manager and other global functions, you’ll engage deeply in design activities, risk management, usability, and post-market processes—with a clear opportunity to shape how quality is embedded into product development and lifecycle decision-making.

Your responsibilities include:

Act as a technical reviewer and independent quality voice in key design and change control processes

Lead the creation, execution, and documentation of Design Verification and Design Validation (DV/DVAL) activities, including protocol development, test case execution, report generation, and resolution of testing issues

Provide design quality input as a subject matter expert and/or independent reviewer, and support internal and external regulatory audits as required

Conduct quality trending and analysis using complaint and NCEP/CAPA systems; lead or support risk analysis activities related to CAPAs and audit findings

Support and enhance the Post-Market Surveillance (PMS) process, including reportability assessments and signal detection activities

Actively contribute to the Design Change process, ensuring that all proposed changes are systematically assessed and fully documented for risk and compliance

Participate in and support New Product Development (NPD) efforts across multiple Neuromodulation franchises

Demonstrate strong working knowledge and application of engineering techniques in compliance with regulatory requirements and internal standards

Operate as a highly cross-functional partner, consulting with product experts, R&D, post-market quality, medical safety, and regulatory affairs to ensure comprehensive and integrated design controls.

Required Qualifications:

Bachelor’s degree in Mechanical, Electrical, Industrial, Biomedical Engineering, or equivalent

7+ years of experience in design quality, R&D, system engineering, or product development in a regulated industry (preferably medical devices)

Proven expertise in ISO 13485, ISO 14971, 21 CFR 820, IEC 60601, IEC 62304, and EU MDR

Strong communication skills and ability to influence across functions and geographies

Please submit Resume in English

Preferred Qualifications:

• Experience in medical electrical systems, or active implantable devices.
• Prior experience mentoring engineers or leading small technical teams within a quality or R&D setting
• Expertise in design controls, including Desing Inputs, Design Outputs, Design Verification, Validation, and Risk Management documentation (e.g. DFMEA, Hazard Analysis, Task Analysis)
• Familiarity with Essential Design Outputs, Bills of Materials, and product lifecycle documentation
• Experience in post-market processes: reportability assessments, signal evaluations, and PMS reports
• Variable and attribute test method development and validation experience
• High comfort level working within a global, matrixed organization