Boston Scientific Senior Design Assurance Quality Engineer Sustaining & NPD 

France, Nouvelle-Aquitaine 

141951958

Hybrid Roles:

Your responsibilities include:

• Creative and resourceful problem-solving skills for moderate to complex mechanical and electrical devices. Including identifying, prioritizing, communicating, and resolving quality issues.
• Working within a team of Sustaining/NPD Engineers (embedded within R&D and Quality Assurance groups).
• Support the design, development, and testing of finished devices and accessories used in Boston Scientific Endoscopy product lines during their entire Development Life Cycle, from the Requirements gathering phase to the End-of-Life phase.
• Creation and review of Risk management/DQA documentation (e.g., Hazard Analysis, Task Analysis, Design Failure Modes and Effects Analysis (DFMEA), Fault Tree Analysis (FTA), Design Validation and Usability Engineering related documentation).
• 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.
• Participate in product, system, and sub-system level design reviews with focus on device design evaluation, product risk mitigation, and other required Risk Management activities.
• Fully conversant with validation techniques and associated regulatory requirements including analysis of customer feedback and complaints.
• 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, Process Validation and Labeling).
• Become a Subject Matter Expert (SME) for design controls and risk management requirements for the products supported.
• Support all aspects of DQA activities during internal and external audits, as needed.

What we're looking for:

Qualifications

• BS in Biomedical, or Mechanical Engineering, or equivalent technical discipline.
• Minimum of 5 years of Medical device engineering experience
• Working knowledge of the FDA, ISO, EUMDR and the medical device industry quality requirements associated with product development, design controls, product risk management, and usability engineering.
• Detailed understanding and working knowledge of US and International regulations including 21 CFR part 820, is required, as well as the Medical Device Directive / Medical Device Regulation, EN ISO 13485, EN ISO 14971 and IEC 60601
• Strong communication (oral and written) and presentation skills.
• Preferred English Level: 80-89%.
• Travel approximately 10-15%, if required.

Expected Behaviors

• Proactive mindset and strong initiative
• Critical and analytical thinking
• Clear and open communication
• Strong attention to detail
• Creativity and problem-solving
• Collaboration and team orientation