Company Description
About us
We believe in the power of ingenuity to build a positive human future.
As strategies, technologies, and innovation collide, we create opportunity from complexity.
Our diverse teams of experts combine innovative thinking and breakthrough technologies to progress further, faster. Our clients adapt and transform, and together we achieve enduring results.
We are over 4,000 strategists, innovators, designers, consultants, digital experts, scientists, engineers, and technologists. And we have deep expertise in consumer and manufacturing, defence and security, energy and utilities, financial services, government and public services, health and life sciences, and transport.
Our teams operate globally from offices across the UK, Ireland, US, Nordics, and Netherlands.
PA. Bringing Ingenuity to Life.
Job Description
We are seeking a highly skilled consultant with experience in medical device development to join our Life Sciences consulting team. This role focuses on the development of medical devices, including a strong understanding of regulatory and quality requirements for medical devices, software as a medical device (SaMD), and/or combination products. The ideal candidate will have experience leading complex technical projects, integrating multidisciplinary expertise, and ensuring regulatory and quality compliance while driving innovation in MedTech and pharmaceutical product development.
Key Responsibilities:
Technical Leadership
- Act as a systems engineering leader, bringing together multi-disciplinary teams - design, mechanical, electrical, software, quality and regulatory - to develop complex medical and drug delivery devices.
- Define system architecture, ensuring alignment with safety, usability, and regulatory requirements (ISO 13485, IEC 62304, ISO 14971, FDA 21 CFR 4/ 820).
- Oversee technical project management, ensuring clear requirements, risk management, and seamless integration of cross-functional expertise.
- Lead end-to-end product development, from user needs analysis and design to development, verification, validation, and regulatory approval.
Regulatory & Quality Compliance for Medical/ Drug Delivery Devices
- Provide expertise on global regulatory requirements for medical/ drug delivery devices, ensuring compliance with FDA, EMA, MHRA, MDR/IVDR, and ISO standards.
- Lead risk management activities (ISO 14971), ensuring safety and efficacy through robust design and process controls.
- Guide processes for hardware, software, and AI-driven medical devices, including compliance with IEC 62304 (medical software lifecycle processes) and IEC 62366 (usability engineering for medical devices).