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Design Control Engineer

Design Control Engineer

We’re looking for a Design Control Engineer to bring regulatory knowledge and rigour to our world leading technology development and product. You will have a passion for detail and excellence, to help us bring the next generation of minimal access, surgical-assist robot to global markets.

Why join us?

CMR is an exciting and evolving company to be joining right now.  Our commitment to our goal of building a world-class medical devices company is underpinned by the ground-breaking innovation of our next generation of surgical robots and a diverse team of talented and supportive individuals.

Our values are to be ambitious, humble, people focused and fair and responsible. If you share these values, our passion for improving lives, and have the desire to make a real difference to the way minimal access surgery is developed and delivered, then it is a great time to join us.

The Role

We’re looking for a Design Control Engineer to bring regulatory knowledge and rigour to our world leading technology development and product. You will have a passion for detail and excellence, to help us bring the next generation of minimal access, surgical-assist robot to global markets.

You will provide coaching, support collaboration and direction that ensures our submissions are delivered to the highest standard enabling entry into global markets. Your collaborative nature and practical approach will enable you to positively manage a range of stakeholders across the global business, to ensure successful outcomes are achieved, and innovations embraced.

Responsibilities

  • Guiding a multi-disciplinary team responsible for medical device development
  • Representing the voice of the customer and the vision of the product throughout the product development process and communicating these to the engineering teams
  • Translating high-level business and user needs into product requirements
  • Identifying applicable regulatory and statutory standards and converting them into requirements
  • Establishing best practices to address problems and accomplish goals in terms of regulatory approval
  • Planning, coordinating and delivering quality, value-added project risk management deliverables  including risk management plans, device, process and usability risk assessments (FMEA, FTA, Task Analysis) per ISO13485
  • Ensuring the implementation of best practice regulatory vision, strategy, policies, processes and procedures to aid and improve business performance
  • Bridging the gap between the Regulatory and Technology function, communicating efficiently and effectively with the both departments to ensure the right outcome
  • Applying strong analytical skills and engineering knowledge to define problems, collect data, establish facts and draw valid conclusions

We’re a high growth company and as such roles change and evolve. We’d expect you to be willing to turn your hand to anything within the Technology and Systems team remit that helps the team deliver its objectives.

About You

A natural communicator hopefully goes without saying, but in addition we’d like you to have:

  • Knowledge of ISO standards, FDA, MDD, MDR and regulations applicable to the design and development of medical devices
  • Understanding of complex electro-mechanical devices
  • Leadership and management experience at a senior level: coaching and managing upwards and horizontally
  • Proven track record for bringing technically complex products to market
  • Experience in a multinational highly regulated industry (automotive, aerospace), including full responsibility for RA at pre-market stage
  • Working knowledge of medical device related standards / regulations
  • Good working knowledge of risk management and GMP and how it applies to medical devices
  • Broad knowledge encompassing engineering disciplines including mechanical, electrical and software
  • A genuine desire to help and support team members so that we can all achieve our best

 

The Package

We offer a competitive salary and a great benefits package. In addition, you’ll be joining a company with a fabulous culture of ambition, creativity and teamwork, and where fun is just as valued as our commitment to make surgery better for millions of people.

 

Interested? We’d love to hear from you!

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