Boston Scientific Senior R&D Engineer 

Ireland, Galway 

353966919

Key Responsibilities

• Leads or supports workstream activities on Next generation calcium products including Cutting Balloon products ensuring product safety, compliance and performance improvements.
• Support marketing in gathering customer feedback on next generation products.
• Product demonstrations at conferences
• Flexibility to travel to US and Europe
• Early conceptual work as part of exploratory in the calcium space
• Development of pilot processes and equipment, Process Design and Development, preparation of specifications, process capability studies, six sigma process testing, report preparation, process/test documentation, transfer of processes from pilot to manufacturing.
• Works independently to plan and schedule own activities necessary to meet timelines.
• Leads or participates in a cross functional team to perform troubleshooting on new products/process problems as related to design, material or process.
• Summarizes, analyses, and draws conclusions from test results.
• Prepares standard reports/documentation to communicate results to technical community.
• Responsible for engineering documentation.
• May train and/or provide work direction/supervision to technicians.
• Works co-operatively with process development, quality, manufacturing, regulatory, clinical and marketing to ensure project success.
• Communicates changes in project milestones and writes project reports as required.
• As a member of the development team they will have significant impact working within the development process to bring product/process through from concept to commercialisation applying Exploratory, Technical Development Process (TDP) and Product Development Process (PDP) methodologies.
• Able to provide technical guidance within a large team and be an effective communicator within a multidisciplinary and international organization.
• Evaluates in conjunction with EHS new equipment/processes/chemicals for environmental impact/effect to eliminate or lessen such impacts/effects.
• Ensure regulatory compliance to GMP’s of all medical device regulatory agencies (e.g., FDA, ISO and MDD).

Education & Experience

• Level 8 Bachelors Degree (240 credits) in Engineering/Science, preferably Mechanical, Materials or Biomedical Engineering.
• 5+ years in a Design /Manufacturing environment.
• Experience with design, fixturing and prototypes development.
• R&D/Technical experience preferably in the Medical Device sector.
• Excellent interpersonal and communication skills.
• Excellent analytical and problem-solving skills.