Project Manager - Product Lifecycle & Sustaining Engineering
LivaNova
Munich, Germany
Mission
The Project Manager for Product Lifecycle & Sustaining Engineering plays a pivotal role in ensuring timely, efficient, and compliant execution of sustaining activities across the product portfolio. As the first point of contact for sustaining R&D work/change requests, the Project Manager is responsible for assessing incoming requests, driving prioritization decisions, and ensuring alignment with business objectives and regulatory requirements. This role supports the continuous improvement and compliance of medical devices on the market by leading cross-functional coordination and resource planning.
Key Responsibilities
- Act as the primary interface for all sustaining engineering and change requests, ensuring structured intake, validation, and documentation of requests from internal and external stakeholders;
- Analyze, challenge, and refine incoming requests, identifying the most appropriate and compliant solutions from both technical and business perspectives;
- Maintain and manage a prioritized sustaining project list, continuously reviewing and updating priorities based on business needs, regulatory timelines, product risk, and resource availability;
- Lead and facilitate cross-functional alignment on project scope, priority, and resource allocation, working closely with core team members from R&D, Quality Assurance, Regulatory Affairs, Manufacturing, Supply Chain, and Technical Services;
- Monitor project plans, critical paths, risk assessments, and implementation timelines for approved sustaining projects;
- Ensure that project execution aligns with applicable Design Control requirements and relevant medical device regulations;
- Serve as a key stakeholder in resource planning discussions, balancing project demands with available functional bandwidth;
- Track and report progress on sustaining projects, escalating risks, delays, or resource constraints proactively to leadership;
- Champion a culture of continuous improvement, compliance, and collaboration within the sustaining engineering framework.
Skills and Experience
- Bachelor’s degree in engineering, Biomedical Engineering, or a related technical field is required;
- Significant experience within the medical device industry, with a focus on sustaining engineering, change control, and lifecycle management;
- Deep understanding of regulatory frameworks and quality systems applicable to sustaining activities;
- Proven ability to manage project intake, prioritization, and execution in a dynamic, cross-functional environment;
- Skilled in evaluating technical change impacts, challenging assumptions, and driving efficient, risk-based decisions;
- Excellent communication, negotiation, and stakeholder management skills;
- Fluent English language skills, written an spoken; German would be a plus;
- Strong organizational and analytical skills, with a proactive, structured, and pragmatic mindset;
- Proficient in PLM systems, project tracking tools, and documentation control processes.
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