NEURO Principal, Design Quality Assurance Engineer HEREDIA

Additional Locations: Costa Rica-Heredia

Diversity - Innovation - Caring - Global Collaboration - Winning Spirit - High Performance

At our company, we value diversity and believe it is our greatest strength. We are committed to empowering women, supporting the LGBTQ+ community, and creating opportunities for individuals with disabilities. Our belief is that your diversity enriches our work environment. As an equal opportunity employer, we wholeheartedly welcome applications from all qualified candidates, regardless of their background. Additionally, we have a Gender Equality Policy that reflects our commitment to fairness and equality in the workplace.

Hybrid Roles:

Boston Scientific's hybrid workplace includes Working From Home and onsite. You will have the opportunity to discuss details in the interview. 

About the role

We are seeking a Principal Design Quality Assurance Engineer to play a critical leadership role within the Neuromodulation Division’s product development lifecycle. This individual will operate in a highly cross-functional, global environment, supporting world-class design for medical devices from early-stage development through the end of the product lifecycle.

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:

·         Serve as a quality systems and compliance lead within cross-functional project teams, supporting Design Controls, Risk Management, Usability Engineering, and Post-Market activities

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

·         Apply systematic problem-solving methodologies to identify, prioritize, communicate, and resolve design quality issues in a timely and collaborative manner

·         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

·         Collaborate with cross-functional design teams to support the development, remediation, and lifecycle management of Risk Management documentation, including Hazard Analysis, Task Analysis, DFMEA, and Software FMEA

·         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.

·         Collaborate across global functions to drive the development of safe, compliant, and patient-centric product designs

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

·         Demonstrated experience operating in cross-functional and cross-site teams, with a track record of technical leadership and ownership

·         Experience contributing to or leading project teams, workstreams, or technical groups with accountability for quality and outcomes

·         English Level C1 80%-90%

·         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

Requisition ID: 606850

As a leader in medical science for more than 40 years, we are committed to solving the challenges that matter most – united by a deep caring for human life. Our mission to advance science for life is about transforming lives through innovative medical solutions that improve patient lives, create value for our customers, and support our employees and the communities in which we operate. Now more than ever, we have a responsibility to apply those values to everything we do – as a global business and as a global corporate citizen.

So, choosing a career with Boston Scientific (NYSE: BSX) isn’t just business, it’s personal. And if you’re a natural problem-solver with the imagination, determination, and spirit to make a meaningful difference to people worldwide, we encourage you to apply and look forward to connecting with you!

Benefits • Life-Work Integration • Community • Career Growth

At Boston Scientific, you will find a collaborative culture driven by a passion for innovation that keeps us connected on the most essential level. With determination, imagination, and a deep caring for human life, we’re solving some of the most important healthcare industry challenges. Together, we’re one global team committed to making a difference in people’s lives around the world. This is a place where you can find a career with meaningful purpose—improving lives through your life’s work.