Design Quality Assurance Engineer I

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. This role supports Neuromodulation division products 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.
• Acts as an effective team member and mentor in supporting quality disciplines, decisions, and practices.
• Work within a cross-functional team to identify and implement effective controls and support integration of design control related products, records, and processes.
• Owns, creates, maintains and/or supports safety risk management processes, including Hazard Analysis, Risk Management Plan, Risk Management Report, and DFMEA.
• Support Post Market activities, as necessary, of risk based on post-market signals.
• 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.
• May provide support to Design Quality Engineers on new product development, acquisitions and sustaining engineering projects.
• Perform quality trending using the complaint and NCEP/CAPA systems. Perform and/or lead risk analyses for CAPA and/or audit findings investigations.

Required Qualifications:

• Bachelor’s degree in mechanical, electrical, biomedical engineering or equivalent
• 1 years of experience in manufacturing, design, risk management, design assurance, post-market quality, or design engineering
• Demonstrated ability to solve complex engineering problems using analysis, experimentation and statistics
• Strong communication and analytical skills
• Ability to effectively work and collaborate in a mixed onsite + remote environment.

Preferred Qualifications:

• Medical device or other regulated industry experience
• Experience with medical standards compliance, including ISO 13485, ISO 14971 and FDA Quality System Regulations with a focus on design controls, design optimization and risk analysis.
• Demonstrated use of Quality tools and methodologies including DFMEA, DOE, Brainstorming, Root Cause Analysis, 5 Why’s.

Requisition ID: 600474

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.