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 lifecyclefrom 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.
Requirements:
* Education: Bachelors degree in Engineering, Computer Science, or related field (Masters preferred).
* Experience: 6+ 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 Skills
* Experience with IEC 60601 standards and ISO14971 risk management.
* Participation in Notified Body audits or technical file reviews
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