Senior Project Manager Imaging Catheter (m/f/d)
Senior Project Manager Imaging Catheter (m/f/d)
WHO WE ARE
We are LUMA Vision, a start\-up based in Dublin (Ireland) and Munich (Germany) developing cutting\-edge innovative imaging technologies to significantly advance healthcare and solve truly global unmet clinical needs. With creativity, passion, and focus, we apply our best\-in\-class engineering and design know\-how to create new hardware, software, and data science technologies. To expand our project management activities, we are searching for a Senior Project Manager Imaging Catheter to join our growing team in Dublin.
YOUR ROLE WITH US
As a Senior Project Manager at LUMA Vision, you will be responsible for overseeing complex projects from inception to completion, ensuring they meet all scope, timeline, and financial requirements. In this specialised role, you will lead the cross\-functional delivery of Intracardiac Echocardiography (ICE) ultrasound\-enabled, steerable imaging catheters.
This critical role spans the entire product lifecycle: driving novel designs out of our Dublin and Munich engineering labs, through strict medical device design controls, and managing the complete design transfer to our global Contract Manufacturing Organisation (CMO) partners for high\-volume commercialisation. This role involves managing larger\-scale projects that require strategic planning and stakeholder management, as well as a detailed technical understanding of catheter assembly processes, cleanroom tooling, sensor integration, and manufacturing yield optimisation. The Senior Project Manager will work closely with cross\-functional teams to ensure project goals are met and deliverables are of the highest quality.
YOUR RESPONSIBILITIES
- Project Planning and Management: Develop comprehensive project plans and manage highly complex technical projects, including timelines, resources, and milestones through the entire catheter product development cycle. Ensure all activities align with the project strategy and goals, coordinating efforts across various teams to maintain progress and quality.
- Comprehensive Budget Management: End\-to\-end management and accountability for the catheter platform project budget. Formulate, track, and forecast project financials, managing capital expenditure alongside operational expenditure. Evaluate complex trade\-off decisions and present actionable financial impact data to leadership stakeholders.
- Compliance and Quality Assurance: Ensure compliance with applicable standards and regulations, including FDA requirements, notified bodies, and ISO standards. Support Design control process and DHF (Design History File) deliverable schedule with key stakeholders.
- Team Leadership and Coordination: Lead and coordinate cross\-functional project teams by mentoring and motivating members, fostering a collaborative and communicative environment. Organise regular meetings to address concerns, resolve technical blockers, and provide valuable feedback, ensuring everyone is aligned with project goals.
- Stakeholder Management: Engage proactively with senior leadership to deliver high\-visibility progress reports, project status updates, and strategic milestone forecasts. Effectively articulate the operational and strategic impact of budget variances, resource gaps, or engineering trade\-offs, securing organisational buy\-in and alignment on critical path adjustments.
- Continuous Monitoring and Adjustments: Continuously monitor project progress against key performance indicators (KPIs) and make necessary tactical adjustments to keep the project on track. Proactively mitigate technical and supply chain risks, addressing any assembly or yield issues that arise during the project lifecycle.
- Vendor Supply Chain Management: Communicate with external material vendors, component suppliers, and component\-level CMOs to ensure design intent is translated into the product effectively. Ensure the on\-time delivery of precision micro\-components and sterilisation validation services within budget to meet strict program timelines.
- Rigorous Design Transfer Planning (21 CFR 820\.30(h)): Author, manage, and execute the formal Design Transfer Plan to ensure lab\-scale engineering outputs seamlessly translate into robust, commercial\-scale production specifications. Drive Design for Manufacturability (DFM) interventions early in the RD cycle. Lead the comprehensive compiling, auditing, and multi\-phased release of the final Device Master Record (DMR)including assembly drawings, materials procurement specs, and incoming quality inspection procedures\-ensuring the CMO replicates exact clinical design intent.
- Quality Lifecycle Process Validation (21 CFR 820\.75\): Collaborate with Quality Assurance, Operations and the CMO to establish strict protocols and acceptance criteria for Installation Qualification, Operational Qualification, and Performance Qualification. Ensure full process capability baseline targets are met before commercial distribution.
- Risk\-Based Compliance Alignment: Enforce closed\-loop integration between risk management (ISO 14971\), design outputs, and the manufacturing line. Lead cross\-functional reviews of PFMEA with the CMO to identify, quantify, and mitigate manufacturing\-induced clinical risks early in the NPI transfer window. Maintain absolute compliance with FDA Quality System Regulations, the updated QMSR framework, ISO 13485, and EU MDR Annex II requirements.
- Innovation and Improvement: Foster a culture of innovation and continuous improvement within the project teams. Contribute to the company’s growing intellectual property portfolio through catheter innovation, assembly improvements, and mechanical design inventions.
- Education: Bachelor’s degree in Biomedical Engineering, Mechanical Engineering, Materials Science, or a related technical discipline from an accredited college or university is required.
- Minimum 10 years’ experience in product development with at least 5 years of direct project management experience leading projects in the medical device industry under strict design controls.
- Catheter Expertise: Deep, hands\-on experience driving intracardiac echocardiography (ICE), intravascular ultrasound (IVUS), endovascular, or complex steerable catheter platforms from initial lab prototyping through verification validation (VV), biocompatibility evaluation, ETO sterilisation validation, and clinical trials.
- Core Competencies: Proven experience leading large\-scale projects and managing cross\-functional teams in a technical development environment. Strong understanding of project management methodologies and design transfer documentation bridges.
- Functional Area Exposure: Experience in functional areas: Hardware Development, Quality Assurance, Clinical/Medical, Commercial, Manufacturing Operations, Cleanroom Processing, Procurement, and Regulatory is preferred.
- Regulated Quality Systems: Highly experienced in working within ISO 13485/FDA regulated quality systems or similarly regulated medical device environments.
- Collaboration Execution: Ability to achieve results in a co\-located organization. Demonstrated experience working with cross\-functional teams, project facilitation, and a proven ability to complete complex projects on time.
- Interpersonal Skills: Excellent leadership, communication, and interpersonal skills. Strong problem\-solving skills and the ability to make quick, efficient decisions in a time\-critical manner.
- Software Tools: Advanced knowledge and hands\-on experience with MS Project, JIRA, Confluence, MS Teams, SharePoint, and MS Office.
- PMO Credentials: Advanced certifications such as PMP (Project Management Professional) are preferred.
- Hands\-on startup mindset with strong problem\-solving skills and great attention to detail also while multitasking.
- Strong work ethics with a team\-oriented mindset, thriving in a rapid\-growth environment.
- Ability to achieve results in an international, co\-located organisation.
- The ability to travel up to 25% annually within Europe as well as internationally.
- Excellent communication skills in English.
- Working on cutting edge imaging systems to the direct benefit of patients and improving healthcare.
- Becoming part of a dynamic, multi\-national team of highly skilled individuals with a very strong focus on team culture and individual development.
- A learning environment where you can extend and build upon your skills and interests.
- Flexible working environment and an international culture as well as offices in Germany and Ireland. Position is based full\-time/hybrid out of our Dublin office.
Would you like to become part of our team?
We would love to hear from you and look forward to receiving your CV and cover letter. Please apply for the position at jobs@lumavision.com.
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