Mechanical Engineer, Instruments

Job Summary

Quantum Surgical is looking for a Mechanical Engineer, Instruments to join a team of creative and energetic engineers who are building the next generation of smart tools for minimally invasive therapies.

The Mechanical Engineer is directly responsible for the design and development of innovative instruments and accessories for an integrated robotized platform with a medical application. He/she can design complex instruments and assemblies related to medical devices, as well as understand materials selection, biocompatibility, cleaning and sterilization requirements. His/her strong technical background enables him/her to generate, prototype and evaluate creative design concepts from design inputs to a sound product design.

The candidate should have demonstrated experience with early stage product development and creation of novel medical instruments.

Key Responsibilities

  • Lead innovation, development, and creation of novel medical Instruments from feasibility prototype to product commercialization
  • Generate concepts for new products, design selected solutions and perform simulation, functional & performance tests
  • Take into account biocompatibility, sterilization and cleaning of instruments issues
  • Perform Failure Modes & Effects Analyses on critical instruments
  • Create specifications and requirements based on clinical, user and safety inputs
  • Collaborate with contract manufacturers to optimize product performance
  • Interface with external suppliers for component and process design
  • Provide technical leadership and knowledge on technology and engineering areas related to instrument and mechanism design
  • Support the Quality team for the analysis & treatment of observed issues

Experiences and Qualifications

  • MS or PhD in Mechanical Engineering, Materials Engineering or equivalent
  • 5 years of experience in the medical device industry
  • Experience in biocompatibility, sterilization, cleaning (ISO 17665 & 10993)
  • Expertise using SolidWorks
  • Experience working in a multi-disciplinary team
  • Experience with product development processes
  • Excellent communication and documentation skills
  • Solid analytical and problem-solving skills
  • Passion for innovation and proven ability to find solutions
  • Self-motivated, creative and open-minded

Desired Experience

  • Familiar with design controls, design transfer, GMP guidelines, FDA regulation
  • Knowledge of design for manufacturing