We are currently working with a ground breaking medical device manufacturing company, who are in a state of growth and therefore looking to recruit a Systems Engineer to their team based at their HQ site near Warwick. As a Systems Engineer you'll contribute to systems development of the company's products, ensuring full compliance with medical device regulations and standards. You'll take a lead in the feasibility, definition, integration and verification of elements of the dialysis products.
Essential Candidate Experience:
• Systems Engineering experience within a regulated industry such as Medical Devices, Automotive, Aerospace, Defence
• V Model Lifecycle Experience
Design and Development
Analyse opportunities for design improvement including but not limited to thermal, acoustic, pneumatic, hydraulic, usability, EMC, electrical safety, functional safety, reliability, weight, cost, assembly & serviceability
Help develop appropriate design solutions through mechanical, electronic and software design, prototyping & experimental testing
Ensure all aspects of the development lifecycle, including elements of requirements definition, design implementation, integration, verification and validation are followed and remain compliant with the approved development process, risk management process and regulatory standards.
Analyse performance of systems, subsystems & components to determine root cause of failures
Formulate solutions to identified problems in conjunction with team members where necessary
Define and apply integration and verification testing to examine the performance of proposed functions of the company's dialysis products
Record test results, interpret, summarise and report findings
Take a lead in reviewing, defining and confirming the system architecture of the company's products
Collaborate and facilitate interaction with relevant peers to drive completion of set tasks
Identify and communicate opportunities for engineering process change to drive efficiency
Provide coaching to assist with the development of junior colleagues
Related Engineering, Science or BioMed Degree; Masters desirable
Experience of working with mechatronic systems
Knowledge of testing, manufacturing and verification processes
Hands-on system-level engineering experience, delivering mechanical, electronic or software designs for complex devices
Experience in volume production solutions, preferably in the healthcare industry (experience in other regulated industries may be acceptable)
Experience of working to the requirements of a Quality Management System (ISO 9001 and/or ISO 1 3485), covering design, verification, production and field support
Sound understanding of risk management principles applied to the development of safety-critical systems
Naturally curious, with a strong analytical mind and ability to solve problems effectively
Good interpersonal skills, capable of working with and leading a diverse team
Mechanical, Electronic or Software Engineering (highly competent, capable of growing the role)
Knowledge of constructional and functional safety principles and standards an advantage.
Knowledge of Risk Management Process principles and standards an advantage.