Program Manager - Edinburgh
At Spacelabs Healthcare, we are on a mission to provide continuous innovation in healthcare technology for better clinical and economic outcomes. Our scalable solutions deliver critical patient data across local and remote systems, enable better-informed decisions, increase efficiencies, and create a safer environment for patients.
Role Overview:
We are seeking a Program Manager to join our Diagnostic Cardiology team in Edinburgh. This team is responsible for developing new products and enhancing existing ones across a portfolio of electronic medical devices, application software, and accessories.
As Program Manager, you will lead global, cross-functional teams through the entire product lifecycle—from concept and development to manufacturing and ongoing maintenance. This is a high-impact role requiring strong leadership, technical expertise, and a passion for delivering innovative healthcare solutions.
Responsibilities:
* Program/project management of a global cross-functional team within a regulated medical device quality
* Lead projects throughout the product lifecycle from concept, development, introduction to manufacture and ongoing maintenance.
* Develop requirements, specifications, schedules, risk analysis, and tradeoff analysis for
* Negotiate schedule, risk, product features and resource trade-offs with the project and program
* Ensure all work products from the team meet Spacelabs processes, QMS requirements, and follow best engineering practice, leading by example
* Ensure contract resources are effectively managed, deliver services and products as promised, and meet our QMS requirements.
* Generate of detailed project planning and process documentation
* Provide frequent communication and formal project/program reviews with senior management, the program team, and others as required.
* Negotiate schedules, risks, product features, and resource trade-offs with project and program teams.
* Ensure that team members (direct or indirect reports) are trained and evaluated on their knowledge and adherence to the Company’s values, Code of Ethics and Conduct, and applicable compliance policies.
* Duties may be modified or assigned at any time to meet the needs of the business.
Requirements:
* Bachelor of Science degree in Engineering, Computer Science, or a similar related degree. A master’s degree is a plus.
* 5+ years' experience in related R&D roles, including Program/ Project Management, Test/ V&V, or Operations Engineering.
* Experience in leading software development, including familiarity with embedded systems, APIs, or firmware integration, is desired.
* Knowledge of FDA, EUMDR, and medical device regulatory and registration requirements, or work in a highly regulated industry, is required (ISO13485, FDA CFR 820:30, IEC 62304).
* Proven ability to deliver results through others, both direct and Proven ability to build/lead dedicated, passionate teams.
* Excellent communication and negotiation skills with all levels inside and outside the organisation
* Robust character and determination to hit goals
* A proactive personality is essential, along with a very high degree of self-motivation
* The ability to foresee potential problems and effectively mitigate them
* Experienced with Microsoft Project
* Will be required to travel to the United States and other locations internationally and must be able to acquire all necessary travel documents
* Must be able to complete job responsibilities working with global time zone needs.
Desirable:
* Experience of some of the following:
* Medical product standards such as the IEC 60601 family
* ISO14971 risk management process
* Participation in Notified Body audits or technical file review