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 Design Quality Assurance Engineer supports a major product category with high visibility which will provide the right candidate with excellent growth potential. Work with high-performance cross-functional sustaining team to ensure safety, quality and compliance of launched products while continuously improving their commercial value through end-of-life. Products transferred to Sustaining Engineering (SE) include internally developed products, Sourced Finished Medical Devices, and acquired products.

This position will be located in Coyol, Costa Rica and will provide close liaison with the BSC Operations team, ensuring appropriate coordination between the Maple Grove, Minnesota design owning team. SE Design Quality Assurance engineer works in close partnership with Operations, Project Management, Regulatory, and Research & Development and focuses on protecting the design intent of a product to meet safety, efficacy, regulatory, and business requirements.

Your responsibilities include:

• Actively promote and participate in a cross-functional teamwork environment.
• Actively participate in the Design Change process to ensure the proposed changes to the products are systemically and thoroughly analyzed and assessed.
• Maintains product risk management documentation (i.e. Hazard Analysis, Fault Tree, FMEAs).
• Supports product Post Market activities such assessment of risk based on post market signals, field assessments, and post market surveillance plans and reports.
• Leads/supports the determination and implementation of Design Controls based on Risk Management, Customer Needs, and Manufacturing Input.
• Leads the development of and coordinate the execution and documentation of Design Validation and Verification activities.
• Applies sound, systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving quality issues.
• Demonstrate good working knowledge and application of validation and statistical techniques to comply with associated regulatory requirements and internal standards.
• Perform regulatory standard assessments and support regulatory submissions to notified bodies.
• Maintain Design History File and Design Input / Output documentation (Product Specification, Component Specifications, and Prints).
• Mentor cross functional team through product development process; specifically, with respect to design control and risk management deliverables

What we’re looking for in you:

Minimum qualifications:

• Bachelor’s degree in an Engineering discipline or related field of study
• 5+ years of experience in design assurance, new product development, or related medical device experience
• Self-motivated with a passion for solving problems and a bias for action
• Hands-on approach to project work and collaboration
• Strong communication skills (verbal & written)
• Demonstrated use of Quality tools/methodologies.
• ISO 13485, ISO 14971 and Quality System Regulations understanding with a focus on Design Controls and Risk Management

Preferred qualifications:

• Previous development and management of complex medical devices
• Previous experience in operations

Requisition ID: 595624

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.