Mechanical Engineerwithin the Urology Division will be responsible for providing support for released products within the Laser Franchise, which consists of Holmium and CO2 laser capital systems, laser fibers and associated accessories. Mechanical Engineersupports growth of products to new markets and leads design changes originating in product improvements, regulatory or supply chain needs. Main Duties:
Conduct root cause analysis of design related field complaints
Lead product improvement design activities
Provide technical assistance for sales and marketing activities.
Support the integration of acquired assets within the laser franchise into the Boston Scientific quality system.
Work in collaboration with Regulatory team to provide and maintain the regulatory design inputs and systems compliance. Own the transfer from regulation/standards to engineering derivatives (impact assessment and deployment).
Support RA team with new markets registrations and regulatory submissions.
Definition, writing and management of Design Inputs and flow down for the sustaining products.
Required Qualifications:
BSc in Mechanical Engineering, Aeronautics or Bio-medical Engineering from a leading university.
At least 4 years of experience as mechanical design / system engineer / BioMedical engineer
Hands on experience with electro mechanical systems
Problems solving orientation
Team player, Highly motivated with ambitions to learn and develop
Strong project leadership capability
Multitasking
Interpersonal skills and excellent teamwork - the ability to meet technical as well as human challenges
Experience in medical devices' quality system, specifically is Risk management file and Design Inputs – an advantage
Experience in CAD tools – an advantage
Familiar with testing according to medical standards - advantage
Good communicational skills in English and Hebrew- Verbal, writing, reading
Good documentation skills
Experience in EMC and Safety certifications – an advantage
Experience in Imaging / Electro-Optical systems - advantage.