Job Purpose (Role Definition):
The Senior Systems Engineer is technically responsible for both new product development and product sustenance activities. This role ensures the successful delivery of projects that meet business objectives in terms of scope, time, cost, quality, and performance.
Main Duties and Responsibilities:
As a key member of the R&D team, the Systems Engineer will:
- Specify and manage system requirements appropriate to the intended purpose of the product, maintaining traceability to objective evidence that they have been met.
- Develop and maintain system architecture and design in alignment with user needs and intended purpose.
- Perform safety risk management activities in compliance with internal processes and medical device industry standards throughout the lifecycle of the product.
- Generate engineering documentation to communicate design intent to downstream design and development teams.
- Contribute to the ongoing development and improvement of engineering processes and tools.
- Lead and support engineering governance activities, including Critical Design Reviews (CDRs).
- Collaborate with V&V teams to support verification and validation, including defect triage and issue resolution.
- Attend and contribute to project meetings, providing technical input, risk assessment, and continuous improvement opportunities.
- Share knowledge and technical expertise across project teams and functional areas.
- Monitor and interpret changes in regulatory standards to ensure design compliance with safety and performance criteria..
Management Responsibilities:
None
Experience and Qualifications Required:
Mandatory:
- Bachelor’s degree (or equivalent) in a relevant engineering or scientific discipline (e.g., biomedical, mechanical, systems, or electrical engineering).
- Background in core systems engineering disciplines: Requirements Management, Architecture Definition, System Design, Verification, Validation, Assurance, and Release.
- Proven analytical and problem-solving skills, particularly in complex or safety-critical engineering environments
- Proficient in requirements engineering and applying safety risk management processes throughout the full lifecycle of a product.
- Proven ability to interpret and apply product-specific standards into robust system design solutions..
- Comfortable working in cross-functional teams and across diverse projects, with the flexibility to adapt to rapidly evolving development priorities.
Desirable:
- Proven experience working in cross-functional, multi-disciplinary development environments, collaborating across engineering, quality, regulatory, and clinical teams.
- Background in research and development within regulated industries, preferably in the medical device sector under ISO 13485, IEC62304 and IEC 60601 compliance frameworks.
- Strong communication and collaboration skills, with a demonstrated ability to work effectively within team settings and a genuine enthusiasm for advancing technology.
Systems Engineer in Croydon employer: Inspiration Healthcare
Inspiration Healthcare is an exceptional employer located in Croydon, offering a dynamic work environment where innovation meets compliance in the medical device sector. Employees benefit from a culture of collaboration and continuous learning, with ample opportunities for professional growth and development. The company's commitment to quality and regulatory excellence ensures that you will be part of a team that makes a meaningful impact on healthcare technology.
