Our client is a leading organisation in the medical device sector, specialising in the development and manufacture of innovative catheter-based medical technologies.
We’re looking for an experienced Project Manager to lead customer development programmes for Class II and Class III medical devices, taking projects from initial concept through to commercialisation.
This is a highly visible, customer-facing role combining technical leadership, New Product Development, programme management, commercial responsibility and stakeholder engagement.
Key Responsibilities
Customer & Stakeholder Leadership
- Act as the primary customer contact and relationship owner for assigned development programmes.
- Lead customer meetings, technical reviews, programme updates, and executive-level presentations.
- Translate customer requirements into clear technical, commercial, and programme requirements.
- Build and maintain strong, long-term customer relationships, proactively managing expectations around scope, timelines, deliverables, risks, and changes.
- Support business development activities, including opportunity assessments, customer visits, proposal development and reviews, and technical presentations.
- Communicate programme status, risks, issues, decisions, and key actions clearly to customers and internal stakeholders.
Technical Leadership
- Partner with technical and engineering leaders to develop catheter-based medical devices, including balloon catheter technologies, braided shaft technologies, delivery systems, and associated catheter platforms.
- Provide technical leadership to multidisciplinary teams throughout concept development, design reviews, risk management, Design Verification (DV), Design Validation (PV/clinical readiness), and design transfer.
- Provide technical direction and support in resolving complex product development and engineering challenges.
- Ensure development solutions meet customer, regulatory, quality, and manufacturing requirements.
- Provide oversight of verification and validation strategies, execution, and reporting.
- Apply knowledge of active medical devices and associated product development requirements, where applicable.
Programme & Project Management
- Lead development programmes through all phases of the medical device product development lifecycle.
- Develop and manage programme scope, schedules, budgets, resources, milestones, and deliverables.
- Drive effective cross-functional execution across Engineering, Quality, Operations, Supply Chain, and Production.
- Identify, assess, and proactively manage programme risks, issues, dependencies, and changes.
- Ensure programmes are delivered in accordance with applicable FDA Design Control, ISO 13485, risk management, and internal product development requirements.
- Provide accurate and timely programme reporting, escalation, and portfolio updates to relevant stakeholders.
Commercial & Contract Management
- Develop, review, and support the negotiation of Statements of Work (SOWs) and related customer agreements.
- Define project scope, assumptions, deliverables, milestones, responsibilities, and timelines.
- Manage scope changes and contractual obligations throughout programme execution.
- Support quotation development, project costing, forecasting, and commercial decision-making.
- Partner with Business Development and Finance to ensure programme objectives align with customer requirements and wider business objectives.
Quality & Operational Responsibilities
- Maintain accurate and timely project documentation, customer records, budgets, forecasts, status reports, and portfolio information.
- Ensure programme records and documentation support quality system requirements and audit readiness.
- Promote effective project governance and consistent application of programme management processes.
- Contribute to continuous improvement initiatives focused on programme execution, product development, operational effectiveness, and customer satisfaction.
Experience / Skills Required:
- 10+ years’ experience within the medical device industry
- Experience developing Class II and Class III medical devices
- Strong experience with catheter-based technologies, particularly balloon catheters and/or braided shaft technologies
- Proven experience leading DV and PV activities
- Strong knowledge of FDA Design Controls, ISO 13485 and risk management
- Significant customer-facing and stakeholder management experience
- Experience managing project budgets, schedules, risks and commercial deliverables
- Experience developing SOWs and supporting commercial/contract negotiations
- Engineering or related technical degree
Desirable: CDMO experience, PMP (or equivalent), international stakeholder experience, and experience taking medical device programmes from concept through to commercialisation.
For a confidential conversation about the role please apply for the role or contact Owen Clancy at oclancy@sterlingengineeringeu.com By applying to this job post you agree that Sterling Engineering may process your personal data for recruitment purpose
