Development Programme Manager

Hologic; Cambridge; On-site; GBP 50,000 - 70,000; Full time

Job summary

A medical technology company in Cambridge is seeking a Development Programme Manager to oversee the timely delivery of new implantable products, ensuring compliance with regulatory requirements. The ideal candidate will have a strong background in project management and experience in the medical device sector, focusing on the development of innovative solutions. This role requires excellent communication and analytical skills to drive project success.

Qualifications

• NPD project management experience in the medical device industry, ideally including implantable devices.
• Experience in planning, organizing and executing projects.
• Knowledge of EU and FDA medical devices regulations and standards.

Responsibilities

• Ensure timely delivery of programme milestones.
• Manage engineering design and development of new medical devices.
• Develop design requirements and lead design reviews.

Skills

Project management

Analytical skills

Technical communication

Education

Background in physics/chemistry/engineering

Job description

Overview

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.

Responsibilities

• Ensure timely delivery of programme milestones, supporting projects across the group in line with agreed budgets and resources
• Manage the engineering design and development of new medical device products at various stages of development leading cross functional teams
• 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
• Actively contribute to the regulatory submission processes to ensure compliance and regulatory approval to ensure successful product launch

Qualifications

• Background in physics/chemistry/engineering or closely related field
• NPD project management experience in the medical device industry, ideally including implantable devices
• Experience in planning, organizing and executing projects, including budgeting, scheduling and resource management
• Knowledge of EU and FDA medical devices regulations and standards with experience in supporting devices during the regulatory submission processes
• Proven project management, organisational and time management skills
• Ability to analyse complex situations, identify potential problems and develop effective solutions
• Excellent presentation skills communicating technical and project requirements
• Well-organised with the ability to work with critical attention to detail and high levels of accuracy