**Work mode**:Hybrid**Onsite Location(s)**:Heredia, H, CR**Additional Locations**: N/A**Diversity - Innovation - Caring - Global Collaboration - Winning Spirit - High Performance**
- At Boston Scientific, we'll give you the opportunity to harness all that's within you by working in teams of diverse and high-performing employees, tackling some of the most important health industry challenges. With access to the latest tools, information and training, we'll help you in advancing your skills and career. Here, you'll be supported in progressing - whatever your ambitions.- Design Assurance Engineer II - Electrophysiology (EP)- About the role:- Your responsibilities include:- 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/supports 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/supports 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.
- Supports and leads the execution and investigation of CAPAs, NCEP, Complaints, Failure Mode Investigations, etc.
Support cross functional team through product life cycle process; specifically, with respect to design control and risk management deliverables.- Required Qualifications:- Minimum of a bachelor's degree in Materials, Mechanical, Electrical, Chemical, Biotechnology, Electromechanical or related field of study.
- English Level desired: 90% or greater.
- Minimum 2 years of experience in Quality Assurance and/or Design Assurance, Sustaining or related medical device experience.
- ISO 13485, ISO 14971, and Quality System Regulations understanding with a focus on Design Controls and Risk Analysis.
- Experience navigating manufacturing and/or supplier variations- Preferred Qualifications:- Self-motivated with a passion for solving problems and a bias for action.
- Ability to manage multiple priorities and work with ambiguity.
- Strong communication skills (verbal & written).
- Proficiency in collaborating with interdisciplinary teams.
- Familiar with EP environment**Requisition ID**:580229- **Job Segment**:Quality Engineer, Biology, Biotech, Medical Device Engineer, PLM, Engineering, Science, Management