We are seeking top talent for the role of Project Manager, New Product Introduction – Intraocular Lenses (IOL).
Purpose
The Project Manager, New Product Introduction – Intraocular Lenses (IOL), will be responsible for the end-to-end management of new intraocular lens development projects, from early concept and feasibility through design, industrialization, regulatory approval, and market introduction. This role provides leadership to virtual, cross-functional project teams and requires frequent collaboration with stakeholders, including teams in the United States. The Project Manager acts as the central integrator across R&D, Regulatory Affairs, Quality, Supply chain Operations, Clinical, Marketing, and external partners to ensure the successful delivery of complex medical device programs.
You will be responsible for:
- Own and drive end-to-end NPI projects for intraocular lenses, including project plans, schedules, budgets, and resource planning.
- Lead virtual, cross-functional teams across multiple time zones.
- Ensure full compliance with Design Control, Risk Management, and Change Management requirements.
- Oversee the creation, maintenance, and approval of project documentation throughout the development lifecycle.
- Ensure adherence to GMP, QSR, ISO 13485, and applicable internal procedures.
- Support regulatory submission activities in close collaboration with Regulatory Affairs and Quality.
- Maintain clear and consistent communication with global stakeholders, including regular interaction with teams based in the EU, US, and APACFacilitate effective governance, escalation, and decision-making within a matrix organization.
Qualifications / Requirements
- Bachelor’s or master’s degree in Engineering, Life Sciences, Physics, Optics, or a related technical discipline.
- 5 – 10 years of relevant project management experience in a regulated, technology-driven environment.
- Demonstrated experience managing medical device NPI projects, preferably involving implantable or ophthalmic products.
- Proven ability to lead global, virtual project teams across multiple time zones.
- Strong knowledge of project management, Design Control, and Risk Management principles.
- Working knowledge of GMP, QSR, ISO 13485, and medical device development processes.
- High proficiency in MS Project and Microsoft Office applications, including Excel, PowerPoint, and Word, for project planning, reporting, and stakeholder communication.
- Experience with project management tools and structured reporting methodologies.
- Fluent in English; Dutch language skills are an advantage.
- Availability to work 100% on site in Groningen, the Netherlands, with occasional international travel.
Preferred Skills
- Agility Jumps
- Business Alignment
- Coaching
- Collaboration
- Continuous Improvement
- Operational Excellence
- Performance Measurement
- Process Control
- Process Improvements
- Project Management Methodology (PMM)
- Project Management Office (PMO)
- Project Reporting
- Project Schedule
- Quality Control (QC)
- Research and Development
- Tactical Planning
- Technical Credibility