System Engineer

Job Summary

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

The System Engineer is directly responsible for the design and development of new product technologies or features to fulfill unmet user needs. He/she will bring his/her unique expertise to serve as the main integrator between the hardware and software functions and ensure the delivery of a high quality, reliable, manufacturable, serviceable and compliant product.

The candidate should have demonstrated experience in a system engineering or equivalent role for the design of complex systems within a regulated environment. He/she will focus on innovation, performance and safety. He/she will interface with engineers (Software, Robotics, Mechanical, Electrical, Test), Quality/Regulatory as well as Project Management, Marketing and Clinical teams.

Key Responsibilities

  • Work cross-functionally and provide leadership to drive the design & development of product features
  • Interact with marketing & clinical teams to define product technical requirements
  • Participate in the risk management and usability engineering activities
  • Lead design reviews, bring up innovative solutions, detect and monitor the reduction of main technical risks, resolve conflicting requirements, ensure proper traceability
  • Leverage system engineering knowledge to decompose complex problems into partitioned & solvable problems
  • Review software and hardware product specifications
  • Support the NPI & manufacturing teams to establish the device DMR
  • Support the RA team to establish the regulatory filings (CE, 510k, etc.)

Experiences and Qualifications

  • MS in Engineering or equivalent
  • 5 years of experience in an industrial environment with broad exposure to hardware / software / system design
  • Technical expertise in one or more engineering disciplines
  • Experience writing requirements and design specifications
  • Pragmatic, customer focus approach
  • Solid analytical and problem-solving skills
  • Self-motivated, curious and open-minded
  • Excellent communication and documentation skills
  • Ability to work across functions and team boundaries
  • Highly proficient in oral and written English

Desired Experience

  • Knowledge of main applicable regulations and standards (ISO, IEC, FDA)
  • Familiar with design controls in an FDA regulated environment
  • Experience with Agile software development methodology
  • Experience modeling or simulating system functionality and performance