Senior Manager - Software & Electronics

At Vectura, we are at the forefront of innovative medical device development, particularly in the field of smart inhaler and nebuliser technology. We are committed to advancing healthcare through cutting-edge design and development of drug delivery devices, offering better solutions for patients worldwide. We are seeking a Senior Manager in Software and Electronics to lead and manage the development of handheld nebuliser devices, contributing to the success of our highly skilled team.

Role Overview: As a Senior Manager in Software and Electronics, you will be an expert in one or more areas related to device design and development, ideally with technical knowledge and experience in handheld nebuliser devices. You will leverage your expertise to guide and shape the company’s capabilities, lead complex device projects, and ensure compliance with relevant industry standards. This role requires a dynamic leader who can manage internal teams, collaborate with external partners, and oversee product development from concept to post-market surveillance.

Key Responsibilities:

Lead Device Development: Responsible for the development of smart inhaler and nebuliser devices from concept through to post-market surveillance. Oversee the design, validation, and risk management processes, ensuring that products meet regulatory standards and requirements.

Team Leadership & Collaboration: Lead and manage both internal and external teams to execute complex projects related to device design and development. Collaborate with cross-functional teams, suppliers, and external partners to ensure timely project completion.

Infrastructure & Project Management: Plan and manage infrastructure projects related to device development. Ensure projects are delivered on time, within budget, and aligned with the company’s objectives.

Regulatory Compliance & Standards: Stay up-to-date with industry standards, best practices, and regulatory requirements (ISO 13485, ISO 24971, 21 CFR 820.30, MDR, EN 13554, IEC 60601, ISO 10993). Implement necessary changes and improvements within device development teams to maintain compliance and ensure continuous improvement.

Product Design Assurance: Manage and oversee the product design assurance packages across the device portfolio, ensuring all design and development documentation is comprehensive and accurate.

Stage Gate Progression: Lead product development through stage gate processes, from initial concept to final product launch and market surveillance.

Documentation & Design Review: Write and review design, validation, and testing documentation for products, test equipment, and processes. Ensure all documentation aligns with regulatory standards and effectively mitigates risk.

Risk Management: Write and review risk management documentation, ensuring regulatory compliance and that all risks are appropriately assessed and minimized throughout the development lifecycle.

Innovation & Technology Integration: Assess the applicability of new technologies, design/analysis tools, processes, and materials to enhance device design and development.

Drive innovation by introducing cutting-edge solutions to improve product performance and patient outcomes.

Continuous Improvement: Use knowledge and expertise to challenge and improve internal working practices, fostering a culture of compliance and continuous improvement within development teams.

Qualifications & Experience:

• Proven expertise in device design and development, ideally with experience in handheld nebuliser or smart inhaler devices.
• In-depth knowledge of relevant regulatory standards (ISO 13485, ISO 24971, 21 CFR 820.30, MDR, EN 13554, IEC 60601, ISO 10993).
• Strong project management skills, with experience leading complex, multidisciplinary teams. Excellent communication skills, both written and verbal, with the ability to write and review technical documentation.
• A proactive problem-solver with a passion for innovation and continuous improvement.
• Ability to work in a fast-paced, collaborative environment, managing multiple projects and priorities effectively.

Join us and be part of a team that’s transforming healthcare through cutting-edge technology!