Senior Design Quality Assurance Engineer

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 WFH and onsite. You will have the opportunity to discuss details in the interview.

About the role:

The Neuromodulation Design Quality Assurance Engineer role will serve on a high-performing, cross-functional product development team to design world class Neuromodulation Systems. In a hybrid work mode, the Senior Design Quality Engineer will work cross-functionally to ensure safety, quality, and compliance of a System. This role supports all Neuromodulation franchises and collaborates with many different cross-functional and cross-site teams. You will support Design Activities, Risk Management and Post Market Surveillance processes.

Your responsibilities will include:

• Is a good team member, 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.

Requisition ID: 600473

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.