Development Programme Manager
Role location: Cambridge, UK
Discover a career with real meaning. One that offers the opportunity to showcase your talents, achieve measurable success and gain immense satisfaction by shaping the future of cancer care.
At Endomag, a Hologic company, we’re redefining cancer treatment and empowering clinicians worldwide with innovative medical solutions.
We are excited to be looking for a talented Development Programme Manager to join our team in Cambridge.
As Development Programme Manager at Endomag, a Hologic company, your role will be to ensure our new implantable products align with Endomag’s strategic goals, are completed on time and within budget, and meet regulatory requirements, including actively contributing to the submission review process. You will manage relationships across the organization and with external partners, ensure compliance with ISO and FDA quality systems regulations, and facilitate effective project execution.
We are looking for individuals with technical expertise, a solid background in project management and experience with product lifecycle development. Excellent communication and stakeholder management skills are a must, along with the ability to lead and motivate teams.
KEY RESPONSIBILITIES
1. Ensure timely delivery of programme milestones, supporting projects across the group in line with agreed budgets and resources
2. Manage the engineering design and development of new medical device products at various stages of development leading cross functional teams
3. Develop and document design requirements; lead design reviews and ensure Design History and Technical Files comply with Endomag’s ISO13485 Quality Management System including our ISO14971 compliant risk management process
4. Actively contribute to the regulatory submission processes to ensure compliance and regulatory approval to ensure successful product launch
KNOWLEDGE, SKILLS & EXPERIENCE
5. Background in physics/chemistry/engineering or closely related field
6. NPD project management experience in the medical device industry, ideally including implantable devices
7. Experience in planning, organizing and executing projects, including budgeting, scheduling and resource management
8. Knowledge of EU and FDA medical devices regulations and standards with experience in supporting devices during the regulatory submission processes
9. Proven project management, organisational and time management skills
10. Ability to analyse complex situations, identify potential problems and develop effective solutions
11. Excellent presentation skills communicating technical and project requirements
12. Well-organised with the ability to work with critical attention to detail and high levels of accuracy
Ready to Make an Impact?