Selexa Life Sciences are delighted to be exclusively partnering with a leading medical device innovator at an exciting stage of its product development journey.
The organisation is developing next-generation medical technologies, combining advanced system architecture, novel innovation and multidisciplinary hardware and software engineering to bring complex products from early-stage concept through to commercialisation.
As part of this continued growth, we are supporting the business in identifying a Systems Lead who can operate at the intersection of hardware, software and systems engineering, taking ownership across the full product lifecycle.
The Systems Lead will be responsible for leading hardware and software functions, owning the software development process and conducting system-level design, integration and verification across existing products and new products in development.
The role will ensure that system architecture, requirements and risk controls across hardware and software are aligned with clinical needs, regulatory standards and business objectives throughout the full product lifecycle.
Key Responsibilities:
DISCOVER
- Contribute to the front-end innovation process, identifying and evaluating emerging technologies across software and hardware
- Develop proof-of-concept and prototype software and/or hardware to support functional prototype development
- Provide technical guidance and review the work of software and hardware engineers during early-stage development
- Support early usability testing and concept validation activities
- Identify software and hardware risks and technical constraints at an early stage, communicating these to the wider team and using insights to inform product development.
LAUNCH
- Act as the Systems Lead for new product development, owning design control, risk management and verification and validation activities across hardware and software functions
- Challenge proposed technical solutions and provide expert guidance to ensure the delivery of high-quality, robust and reliable hardware and software
- Collaborate closely with cross-functional teams to ensure product development activities remain aligned with regulatory, clinical and business requirements.
IMPROVE
- Support Quality teams in investigating complex field issues, complaints and non-conformances relating to hardware and software
- Lead initiatives to improve the cost, reliability and performance of existing products
- Identify opportunities for continuous improvement across systems, processes and product development.
Personal & Professional Attributes
- Self-motivated and proactive, with the drive to identify and solve complex technical challenges
- Willing to work collaboratively across disciplines and contribute beyond core responsibilities when required to achieve team and business objectives
- Pragmatic and solutions-focused, with the ability to challenge the status quo and develop innovative approaches.
Experience & Qualifications:
Required
- Bachelor’s degree or equivalent qualification in Software Engineering, Computer Science, Electronics, Electrical Engineering or a related discipline
- 10+ years’ experience in software, hardware or systems development within a regulated environment
- Experience developing Linux-based products, ideally within a regulated medical device or safety-critical environment
- Expert-level knowledge of either software or hardware development, with strong cross-functional understanding of the complementary discipline
- Strong understanding of design control processes, requirements management and version control
- Strong experience in testing, technical documentation and cross-functional product development
- Experience working across the complete product lifecycle, from concept and development through to launch and post-market support
- Understanding of cybersecurity and patient safety principles.
Preferred
- Knowledge of analogue and digital circuit design and power management
- Previous experience within the medical device, healthcare technology or other highly regulated product development environments.
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