NPI Project Manager

The New Product Introduction (NPI) Project Manager will lead the NPI process within a small but dynamic R&D department working on Medical Devices. As a member of a growing Contract Development and Manufacturing Organisation (CDMO), you will play a pivotal role in managing the introduction of new products and technologies from concept through to commercialisation. This includes overseeing project timelines, resources, budgets, and ensuring compliance with all regulatory requirements. The role will work closely with internal teams (R&D, Quality, Regulatory, and Manufacturing) as well as external clients, ensuring smooth execution of NPI projects while maintaining high standards of quality and customer satisfaction.

Key Responsibilities:

• Project Leadership and Management:
• Lead NPI projects by managing and coordinating all activities related to the introduction of new products, ensuring alignment with customer requirements, internal resources, and regulatory standards.
• Develop detailed project plans for each NPI, outlining scope, timelines, milestones, budgets, and risk management strategies.
• Ensure that key project milestones are met on time, within scope, and within budget while maintaining high-quality standards.
• Cross-Functional Collaboration:
• Collaborate with R&D and Engineering teams to ensure that product designs meet customer specifications and regulatory requirements and are manufacturable within the CDMO environment.
• Coordinate with Quality and Regulatory teams to ensure NPI projects comply with industry standards and regulations, including ISO 13485 and other relevant certifications.
• Work with Manufacturing to ensure a smooth handover from R&D to manufacturing, supporting scale-up activities and addressing any technical challenges in the transition to production.
• Client and Stakeholder Management:
• Act as the primary point of contact for clients, ensuring clear communication and alignment of project expectations, timelines, and outcomes.
• Provide regular updates to senior management, clients, and other stakeholders on project progress, potential delays, and mitigation strategies.
• Risk and Issue Management:
• Identify potential risks related to technical, regulatory, or operational challenges early in the process and develop strategies to mitigate them.
• Address issues that may arise during the NPI process, ensuring timely solutions are implemented to prevent delays or quality concerns.
• Compliance and Documentation:
• Ensure that NPI projects adhere to all relevant regulatory requirements, including those set by the MHRA, FDA, or other applicable bodies.
• Maintain accurate and detailed project documentation, including design history files, technical files, and change control records in line with industry standards.
• Continuous Improvement:
• Identify opportunities for improvement in the NPI process and work to implement best practices across future projects.
• Facilitate post-project reviews and capture lessons learned to improve efficiency and the quality of future NPI efforts.
• Resource and Budget Management:
• Manage and allocate resources (personnel, equipment, budget) effectively to ensure timely project execution.
• Monitor project costs and ensure that the project stays within the agreed budget, reporting any discrepancies or potential overruns to senior management.

Essential Attributes:

• Minimum of 3-5 years' experience in a project management role within a CDMO, medical device, or pharmaceutical industry.
• Proven experience managing NPI projects from concept to commercialisation, particularly within a regulated environment.
• Experience working with cross-functional teams in R&D, Quality, Regulatory, and Manufacturing departments.
• Strong project management skills, with experience in planning, execution, and delivery of projects within a set timeframe and budget.
• Knowledge of regulatory requirements for medical devices or pharmaceutical products (e.g., ISO 13485, GMP, FDA, etc.).
• Excellent communication, interpersonal, and organisational skills.
• Ability to manage multiple projects simultaneously and prioritise tasks effectively.
• Experience with project management software (e.g., MS Project, Jira, or similar tools).
• Strong problem-solving and analytical skills.

Qualifications / Certificates / Licenses:

A degree in Engineering, Life Sciences, Chemistry, or a related discipline. A project management certification (e.g., PMP, Prince2) is highly desirable.

Desirable Attributes:

• Experience working in a small, fast-paced team environment across multiple disciplines.
• Knowledge of innovation management practices and IP.
• Familiarity with Lean or Six Sigma principles.