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Role: Senior Systems Architect - Implantable Medical Devices

Experience: 10+ years relevant experience with an advanced Degree/PhD in technical, engineering or science discipline

 

Role Description:

You are a well rounded Systems Engineer, ready to be involved in all project activities related to product development of Class II and Class III electro-mechanical and software systems from definition and concept phase through to implementation. You are known as a problem solver and a team player with excellent communication skills. You understand how to engage stakeholders and factor in their needs. Documentation doesn’t faze you and you are well organised. You love the idea that the work you will be doing ultimately will be making a difference to people’s lives.

 

ESSENTIAL RESPONSIBILITIES: 

  • Plan, manage and implement system engineering activities in projects.
  • Collect and analyse design inputs (customer needs, business needs, etc.) and transform them into high quality engineering requirements.
  • Define and manage from stakeholders needs and perform risk management in projects and maintain the risk management file.
  • Collaborate with several engineering disciplines including Software, Electrical, Mechanical and Manufacturing engineering to ensure effective design.
  • Work with Quality, Clinical and Regulatory teams to ensure product complies to requirements and expectation of regulatory bodies.
  • Prepare and participate in review of requirements, design and testing.
  • Improve System Engineering practices.
  • Ensure the system meets internal needs and international standards by direct execution of verification and validation activities including development of Plans, Protocols and Reports
  • Write technical reports and presentations when appropriate.
  • Establish and manage tools associated with the conduct of the Systems Engineering processes.

ESSENTIAL KNOWLEDGE AND SKILLS:

  • 7+ years engineering experience in product development in a regulated industry.
  • Bachelor’s degree or higher in an Engineering discipline.
  • Strong problem-­solving and leadership skills.
  • Ability to learn and understand complex systems.
  • 5+ years’ experience in Systems Engineering.
  • Experience in taking medical device designs through the regulatory approval process.
  • Strong working knowledge of ISO 14971 and ISO 13485.
  • Experience interfacing with physician customers and therapy consultants.
  • Experience developing software applications, security arch. and data analytics .
  • Experience developing medical hardware.
  • Experience developing system definition, system design and requirements, requirement tracing to subsystems and interface requirements, and system verification and validation strategy and testing.
  • Experience with systems engineering principles, including requirement analysis and allocation, architecture, verification, and validation.
  • Demonstrated experience translating clinical workflow into software design.
  • Good understanding of software development practices for medical device software as well as non-medical software within a medical device system.
  • Excellent verbal and writing skills, including presenting
  • Demonstrated ability to work effectively with others on cross-functional teams.

PREFERABLE KNOWLEDGE AND SKILLS

  • Experience in writing requirements, specifications, test protocols and design documents using a documented development methodology.
  • Experience with Requirements Management Software such as Jama or Doors.
  • Knowledge of engineering statistical tools/methods such as DOE, Monte Carlo, Minitab, ANOVA, (DFLS, DFSS, or DRM Green or Black Belt certification a plus).
  • Basic knowledge of anatomy/physiology.
  • Demonstrated commitment to continuous improvement by studying and applying technical advances in area of expertise.

No agencies please

 

 

Learn about Life at CCWhat to expect when applying

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Benefits

  • Competitive salary, based on merit and reviewed annually
  • Company profit share scheme in addition to basic salary
  • Pension scheme
  • Life, disability and travel insurance, plus private healthcare
  • Free canteen - breakfast, lunch and refreshments
  • 25 days annual holiday plus public holidays, with flexibility to carry over / borrow
  • Relocation assistance if applicable
  • Excellent career development and training opportunities
  • Flexible working hours
  • Social committee
  • Discounted train season tickets, through Travel Plan Plus
  • Free shuttle service to/from Cambridge North train station, through Cambridge Science Park

Future prospects

Cambridge Consultants is committed to developing its employees' careers and has a flexible policy for individual capabilities and preferences. Promotion is linked to merit.

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