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Cambridge Consultants

Cambridge Consultants

Lead Software and Systems Architect (Medical Devices) Ref 1004

We are looking for a talented technical leader to help us design complex Medical Devices with a significant safety-critical software component. You will have the opportunity to lead the development of exciting new products in the areas of Surgery, Drug Delivery, In-Vitro Diagnostics and Digital Health.

  • Do you have a track record in designing complex Medical Devices?
  • Are you an experienced software architect equally comfortable with talking to optical physicists, human factor engineers and marketers?
  • Are you familiar the regulations governing the development of medical software?

This is a challenging senior technical leadership position that requires significant experience and a track record in delivering complex Medical Devices with safety-critical software component within the necessary regulatory framework. You will be providing technical leadership to multidisciplinary teams that design novel Medical Devices and be expected to contribute to the whole development lifecycle from concept to validation.

Cambridge Consultants Medical Technology Division develops cutting edge medical devices using rigorous processes whilst maintaining an informal and friendly environment. It is a great place to work, encouraging innovation and filled with people with a real passion for excellence in engineering.

Main Role

As a technical leader you will be responsible for providing cutting edge technology solutions for our clients. You will be working in a fast paced environment often to tight deadlines and with significant client interactions at senior level. You will be leading technical teams of talented and highly motivated people working on complex multidisciplinary projects with a large software component that will also include people from branches of engineering other than software. You will use your excellent software and system design skills to define the technical solution and, alongside with the project managers, the work programme to deliver the solution in the required time and budget or the estimation of time and budgets. You will be involved in all stages of the development lifecycle, from initial concept generation through to final delivery as well as Quality Assurance and Risk Management processes.

Type of Work

The Medical Software Group is part of the Medical Technology Division which undertakes the development of innovative Medical Devices and In-Vitro Diagnostics equipment from concept to manufacture, often incorporating considerable technical challenges. The division's activities fall into four focus areas:

  • Drug Delivery, including break through inhalation and injection devices
  • Digital Health, including development of innovative connected solutions for medical devices located both outside and inside the body with the use of novel antenna design, as well as for mobile platforms
  • Surgical and Interventional Products covering sophisticated surgical tool and implantable devices
  • Medical Diagnostics and Instrumentation ranging from over the counter personal diagnostics e.g. digital pregnancy test through to instrumentation for use in hospital laboratories

Our projects are often multidisciplinary, where software is just one part of larger system and you will work side by side with other talents, such as human factors engineers, optical physicist, electronics and mechanical engineers. Software development for medical devices follows a rigorous approach guided by standards such as IEC 62304 and streamlined by the use of a suite of software engineering tools and techniques such as continuous integration, static code analysis, test automation and code generation.

Responsibilities

Your responsibilities will include:

  • Using your strong client facing skills to ensure smooth project deliveries
  • Using your strong analytical skills to understand client requirements, drivers and foresee technical challenges and risks
  • Working with project managers to define the overall work programme and estimating time and budget
  • Working with business developers to identify opportunities
  • Leading multidisciplinary technical teams, resolve technical trade-offs
  • Reviewing the technical work of others (documents and code) and sign-off technical documents
  • Coaching less experienced engineers
  • Ensuring project work is carried out in compliance with applicable regulations

You will be expected to work on multiple projects at once and the role may include some travel.

Requirements

To meet the requirements of this role, in addition to an excellent degree (post-graduate preferred) in a relevant subject such as software engineering, electronics engineering or computer science, you will have:

  • Track record in developing software for medical devices in a technical leadership role
  • Strong all-round background in software development with emphasis embedded systems including:

           o real-time software with and without the use of an RTOS

          o safety-critical software

          o familiarity with the most common software engineering tools

          o strong knowledge of the C programming language

          o a working knowledge of UML

  • Strong client-facing skills and the ability to communicate to a non-technical audience
  • Software estimation skills
  • A good understanding of IEC 62304, IEC 14971 and the FDA guidance on medical software
  • A solid general science background In addition, any experience of the following would be advantageous:
  • Knowledge of robotics, control theory, digital signal processing or computer vision
  • Deep technical knowledge of industry standard communication protocols
  • Experience with software development on a wide range of platforms such as Windows, Linux Android, iOS
  • Experience with safety analysis techniques such as FMEA, FTA or HAZOP in the context of software intensive systems

Although the emphasis on specific experience in the medical industry, strong candidates with similar experience in other highly regulated industries, such as aerospace, nuclear, or automotive may still be considered.

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Organisation:  Cambridge Consultants