Boston Scientific Quality Engineer II 

France, Nouvelle-Aquitaine 

381940325

Your responsibilities include:

• Contributing to all aspects of Design Quality Assurance activities in an FDA/EU MDR regulated environment.
• Working within a cross functional team of Sustaining Engineers and Specialists such as:R&D, Regulatory Affairs, Marketing, Medical Safety, Manufacturing, Quality, Production and others.
• Supporting the design, development, and test of finished devices and accessories in the Boston Scientific Endoscopy division during their development life cycle, focused on sustaining existing products on the market.
• 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 and Labeling).
• Participate in product, system, and sub-system level design changes with focus on device design evaluation, design controls, product risk mitigation, and other risk management activities.

• Champion compliance to company policies, work instructions and SOPs.

• Support the creation, review and maintaining of risk management documentation such as: Hazard Analysis, Task Analysis, Design Failure Mode and Effects Analysis (DFMEA), Fault Tree Analysis (FTA) and Usability Engineering documentation.
• Applying sound, systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving quality issues (i.e 5 Whys Analysis, Is-Is Not Analysis, Cause and Effect Analysis and DMAIC problem solving methodologies).
• Participating in Value Improvement Projects (VIPs), cost reduction initiatives such as: new suppliers, alternate materials, design changes, etc.
• Support DQA activities during internal and external audits, as needed.
• May perform other duties as directed

What we’re looking for in you:
Minimum Qualifications

• BS in Biomedical, Mechanical Engineering, or related technical discipline.
• Minimum of 2yearsof medical device or related engineering experience.
• Strong communication and presentation skills.
• Problem solving and critical thinking skills.
• Competent with use of Microsoft Office Suite andMinitab statistical analysis software (or equivalent).
• Ability to collaborate and work in a global team.
• Position located in Coyol, Costa Rica.
• Willing / able to travel approximately <10% of the time.

Preferred Qualifications

• 2+ years of medical device engineering.
• Knowledge of medical device risk controls / risk management.
• Familiar with FDA QSR, EN ISO 13485, EN ISO 14971, and IEC 60601 regulations and standards.