Boston Scientific Sr Design Assurance Engineer HEREDIA 

Costa Rica, Heredia 

550208828

Costa Rica-Heredia

Hybrid Roles:

Your responsibilities include:

• Work cross-functionally with R&D, project management, manufacturing, regulatory, clinical and marketing to ensure project success.
• 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 & 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.
• Demonstrate good working knowledge and application of 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.
• 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, Electromechanicalor related field of study.
• English Level desired: 90% or greater.
• Minimum 5 years of experience in Quality Assurance and/or Design Assurance, Sustaining, R&D, Manufacturing 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.
• Please submit Resume in English

Preferred Qualifications:

• Strong understanding of NCEP/CAPA processes
• Previous experience working to create/maintain risk documentation such as FMEAs and Has
• Experience working with Stature or FMEA MED-8 software would be excellent, but is not required
• 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