Systems Engineering Manager
Application Deadline: 5 June 2024
Department: Engineering
Employment Type: Full Time
Location: Oxford
Reporting To: COO
Description
Want to be part of a team transforming healthcare?
We are looking for an experienced Systems Engineering Manager to join our team. Working within the Engineering department, you will be responsible for overseeing the delivery of system requirements for Adaptix R&D and products, Verification and Validation of these requirements, and the documentation of these in line with the Adaptix Quality Management System.
You will work cross-functionally with an awareness of wider business needs to ensure collaborative delivery on existing and future products in support of the company’s mission to transform Radiology.
The Company
Medical imaging helps patients by enabling early and accurate diagnosis. However, 2D X-rays can be inconclusive as they give a fundamentally limited view of our 3D bodies. 3D images are possible with CT scanners but these are much more expensive, give a high dose of radiation and moving a critically ill patient to a scanner can be labour-intensive and risky.
At Adaptix we are helping make 3D imaging more accessible to the people who need it by producing mobile flat-panel X-ray systems that can be brought to patients giving low-cost, low-dose imaging.
Candidate Profile
As our ideal candidate, you will have a minimum of an undergraduate degree in a science-based discipline or equivalent experience.
Key Responsibilities
Main duties and responsibilities:
* Provide systems leadership to cross functional engineering teams, including design and quality
* Day to day line management for direct reports including responsibility for work planning, training, leave and performance management, escalating issues to the COO for support as appropriate
* Manage the systems engineering activities according to industry best practice including specification, usability, design, reviewing and testing compliant with relevant standards including IEC 62304, 60601 series and 62366
* Prepare documentation for regulatory submissions for new products in line with the Adaptix Quality Management system, working closely with the Quality department
* Prepare and support delivery of technical reports, requirements and test specifications for hardware, software and firmware used in company products, liaising closely with Engineering and Product colleagues
* Lead the engineering approach to product security, including advising on suitable standards and developing new processes, such as threat analysis
* Ensure requirements comply with INCOSE best practice as defined in ISO/IEC/IEEE 29148:2011 Systems and software engineering
* Develop and maintain a requirements set for the product lifecycle management software tools necessary to comply with relevant medical product standards.
* Share knowledge with colleagues in requirements management, product standards, quality and engineering processes
* Take ownership for own project work, lead projects and identify and prioritise critical tasks in order to meet project delivery deadlines.
* Work with colleagues to plan future product development in line with company objectives
* Assist with the build and progression of prototype products and develop these into production assemblies
* Work in accordance with the company’s quality procedures and processes
* Maintain a safe working environment and follow all protocols to ensure compliance with company and regulatory standards
Skills, Knowledge and Expertise
Skills:
* Writing clear, unambiguous, testable requirements
* Ability to rapidly assimilate technical and scientific knowledge
* Ability to apply systems knowledge to improve engineering processes
* Expert knowledge of requirements and test management control databases
* Outstanding written and verbal communications skills
* Thorough understanding of integrated hardware and software systems
* Verification and validation testing including unit testing, integration testing and whole system testing
* Ability to achieve project delivery deadlines in an agile environment
Experience:
* Proven track record of documentation delivery to achieve medical regulatory requirements
* Leading and overseeing software testing, with a focus on usability testing and system testing
* Working according to ISO 13485 and other medical product regulatory standards
* Successful management of projects involving hardware architecture, embedded software design, motor and control feedback circuits, sensors, mixed signal circuit design and PCB layout
* Scoping work and completing tasks within schedule and budget
Apply Now
This is a permanent full-time role based at our R&D offices in Begbroke Science Park, Oxfordshire. Compensation is competitive and commensurate with experience.
Please note the closing date for applications, however, should we find a suitable candidate before this date, the position may be filled earlier. Please note that we are unable to provide sponsorship for visa applications for this role.
If you feel that you would excel in this role we would be delighted to hear from you!
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