Boston Scientific Engineer II Design Quality 

France, Nouvelle-Aquitaine 

410093337

Hybrid Roles:

About the role:

Provides quality engineering support to operations, product development and sustaining functions for current products on the market. Develops, establishes, and maintains quality-engineering methodologies, systems, and practices which meet BSC, customer, and regulatory requirements. Serves as a Quality representative to improve awareness, visibility, and communication on quality initiatives to support assigned departmental, functional, site, divisional and corporate quality goals and priorities. Provides quality engineering support within technical development projects, new product development projects, sustaining existing product families, or system/services support.

Your responsibilities include:

• Support collection and analysis of key quality trending information and data for Management Review and Complaint Reviews.
• Understand and support linkage of field data and Risk Management.
• Provide quality and compliance input for post market product sustaining activities, such as design changes, supplier auditing and surveillance, design concessions, product CE marking and safety certification, customer complaint investigations, NCEP’s, CAPA’s PIRs, Field Signals Evaluations and Field Actions.
• Apply sound, systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving quality issues (i.e 5 Whys analysis, Is-Is Not analysis, DMAIC problem solving methodologies).
• Working knowledge of Design Controls. Provide quality and compliance input to project teams for project decisions and deliverables (i.e Design Change Analysis, Design Inputs, Design Outputs, Test Methods, Design Reviews, Design V&V, Usability Testing, SW Validation, Process Validation and Labeling).
• Provide quality guidance to assure country specific compliance.
• Champion compliance to company policies, work instructions and SOPs.
• Support effective quality assurance, process controls and metrics using data and statistical analysis to drive improvements and actions for manufacturing and assembly of products.
• Support internal and external regulatory audits as required.

What We’re Looking For:

• Minimum of a BS in Life Science preferably Mechanical, Biomedical Engineering, or related field.
• Minimum of 2-3 years of Medical device / risk management experience required.

• Strong communication and presentation skills.
• Competent with use of Microsoft Office Suite, Minitab Statistical Analysis software (or equivalent).
• Ability to collaborate and work on a global team.
• Position located in Coyol, Costa Rica.
• Travel approximately <10%.