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.