Your Job
Are you a systems thinker who thrives on solving complex technical challenges in a highly regulated environment? Join us at Phillips Medisize, where you will be at the forefront of innovative drug-device combination product development. As a Principal Engineer – Systems Assurance Engineer, you will take a leading role in the design, development, and assurance of our smart inhaler technologies and connected medical devices.
This role is pivotal in ensuring our active medical devices meet both regulatory requirements and high-performance standards while supporting rapid product development cycles at our Cambridge site.
What You Will Do
As the Principal Engineer – Systems Assurance Engineer, you will:
• Lead the design and development of mechatronic systems for medical devices, including mobile health connectivity for smart inhalers.
• Define and manage design input requirements and technical product specifications.
• Develop and maintain comprehensive Design History Files throughout the device lifecycle, covering risk assessments, design outputs, V&V, and regulatory documentation.
• Ensure alignment with applicable standards, internal processes, and regulatory expectations.
• Act as Subject Matter Expert for medical device mechatronics, offering guidance across cross-functional teams.
• Communicate technical data effectively to senior leadership and key stakeholders.
• Support the integration of device mechatronics into manufacturing processes, including process validation and industrialisation activities.
• Engage with and manage external partners and suppliers to ensure delivery against quality and technical milestones.
• Contribute to the development and improvement of internal mechatronics standards and lifecycle processes.
• Lead project planning efforts, ensuring alignment with timelines, budgets, and resource allocations.
Who You Are
• Degree in Computer Science, Engineering, or a related discipline.
• 7–10 years of experience in medical device development, particularly in inhalation and/or ventilation.
• In-depth understanding of medical device/combination product lifecycle, design assurance, and regulatory compliance.
• Hands-on expertise in software architecture, embedded system development (C, C++), and UI design.
• Proficiency with LabVIEW, smartphone app programming, databases, and cybersecurity for medical applications.
• Experience designing PCBs and implementing hardware abstraction layers (HAL) for ARM Cortex-M4 processors.
• Proven project management capabilities.
• Strong experience in mechatronics development, design verification and validation, and design documentation.
• Understanding of networking protocols and transitioning designs into production.
What Will Put You Ahead
• Prior involvement in regulatory submissions and audits (e.g. MHRA, FDA, Notified Bodies).
• Mentoring and coaching of junior engineers or team members.
Additionally, everyone has individual work and personal needs. We seek to enable the best work environment that helps you and the business work together to produce superior results.
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