- Work cross-functionally with R&D, project management, manufacturing, regulatory, clinical and marketing to ensure project success.
- Able to understand device performance and anatomy interaction and identify opportunities for device and procedure improvements.
- Leads the determination and implementation of Design Controls based on Risk Management, Customer Needs, and Manufacturing Input.
- Maintains product risk management documentation (i.e. Hazard Analysis, Fault Tree, FMEAs).
- Leads the development of and coordinates the execution and documentation of Design Validation and Verification activities.
- Applies sound, systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving quality issues.
- Leads the execution and investigation of CAPAs, NCEP, Complaints, Failure Mode Investigations, etc.
- Expertise in the validation and statistical techniques to comply with associated regulatory requirements and internal standards.
- Able to navigate gray space by applying risk-based criteria to prioritize project work.
- Leads cross functional team through product life cycle process; specifically, with respect to design control and risk management deliverables.
- Ability to work with minimal supervision and self-learning skills.
- Minimum of a bachelor's degree in Materials, Mechanical, Electrical, Chemical, Biotechnology, Electromechanical or related field of study.
- English Level desired: 80-89%.
- Minimum 5 years of experience in Quality Assurance and/or Design Assurance, New Product Development, or related medical device experience.
- ISO 13485, ISO 14971, and Quality System Regulations understanding with a focus on Design Controls and Risk Analysis.
- Self-motivated with a passion for solving problems and a bias for action.
- Ability to manage multiple priorities and work with ambiguity.
- Hands-on approach to product development.
- Strong communication skills (verbal & written).
- Proficiency in collaborating with interdisciplinary teams.
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Engineer Sr, Design Assurance - Heredia, Costa Rica - Boston Scientific
Descripción
Additional Locations: N/A
Diversity - Innovation - Caring - Global Collaboration - Winning Spirit - High Performance
At Boston Scientific, we recognize that nurturing a diverse and inclusive workplace helps us be more innovative and it is important in our work of advancing science for life and improving patient health. That is why we stand for inclusion, equality, and opportunity for all. By embracing the richness of our unique backgrounds and perspectives, we create a better, more rewarding place for our employees to work and reflect the patients, customers, and communities we serve. Boston Scientific is proud to be an equal opportunity and affirmative action employer and has been recognized with the Catalyst Award in 2022, a prestigious recognition of diversity, equity and inclusion excellence. Also, we have a Gender Equality Policy to support our commitment.
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:
We have an exciting opportunity for a Design Assurance Engineer supporting front end EP division. This position supports several product categories with high visibility which will provide the right candidate with excellent growth potential, commercial experience, and perspective in the medical device industry. The DA Engineer will work with a high-performance cross-functional team to ensure safety, quality, and compliance of products to deliver the highest quality product to the customer.
Your responsibilities include:
Required Qualifications:
Preferred Qualifications:
Requisition ID: 579566
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.
