Job Description

Overview:

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:
Drive new product development programs from concept to completion, ensuring delivery on time and within budget. Lead and mentor project teams, enforcing best practices and compliance with company policies and regulatory standards. Develop detailed project plans, requirements, specifications, schedules, and risk analyses. Negotiate trade-offs between schedule, resources, and product features. Ensure adherence to ISO13485, FDA CFR 820:30, and IEC 62304 standards. Provide regular updates and formal reviews to senior management and stakeholders. Manage contract resources and ensure quality deliverables. Uphold Spacelabs' core values: Integrity, Innovation, Accountability, and Teamwork.

Qualifications:
Education: Bachelor's degree in Engineering, Computer Science, or related field (Master's preferred). Experience: 5+ years in R&D roles, including Program/Project Management. Proven track record leading cloud software platform development with hardware integration. Familiarity with embedded systems, APIs, and firmware integration. Strong knowledge of medical device regulations (FDA, EUMDR) and quality systems. Excellent leadership, communication, and negotiation skills. Highly proactive, detail-oriented, and able to anticipate and mitigate risks. Proficiency in Microsoft Project and advanced MS Office skills. Ability to work across global time zones and travel internationally.

Desirable Ski

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Experience with IEC 60601 standards and ISO14971 risk management. * Participation in Notified Body audits or technical file reviews.