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For Companies At a Glance
- Tasks: Lead the development of innovative medical devices from concept to global approval.
- Company: Join a pioneering company in the medical device industry.
- Benefits: Attractive salary, health benefits, and opportunities for professional growth.
- Why this job: Make a real difference in healthcare by developing life-changing devices.
- Qualifications: Degree in engineering or related field with extensive experience in device development.
- Other info: Collaborative environment with a focus on innovation and quality.
The predicted salary is between 48000 - 72000 £ per year.
This role leads the end-to-end development of medical devices and combination products, from early concept through to global regulatory approval. The Device Development Lead oversees multidisciplinary project teams, manages external design partners, ensures compliance with device regulations, and drives successful delivery of device programmes.
Key Responsibilities
- Project Leadership
- Lead multidisciplinary project teams in the development of drug delivery devices and lifecycle management activities.
- Manage project scope, timelines, quality and cost across assigned device programmes.
- Coordinate closely with formulation, manufacturing and co-development teams to support integration of devices into broader product development plans.
- Device Development & Design Control
- Take full accountability for all stages of device development, including:
- Concept evaluation & Design development & Risk management
- Industrialisation and transfer to manufacturing
- Apply design control principles and ensure all activities meet regulatory and quality system requirements.
- Support the device change control process and ensure timely, compliant implementation.
- External Partner Management
- Manage design and development activities carried out by external design houses and contract manufacturing organisations.
- Provide input on supplier specifications, component requirements and technical capability assessments.
- Regulatory & Quality Support
- Contribute to global regulatory submissions (e.g., IND, IMPD, BLA, MAA, CTD) for device components of combination products.
- Support investigations related to device performance in clinical or commercial use.
- Provide technical support for complaint investigations and device-related queries.
- Ensure all work complies with GxP, safe working practices, and relevant standards.
- Human Factors & Usability
- Provide input into human factors and usability studies for new and existing device platforms.
- Ensure device performance requirements are clearly defined and appropriately tested.
- Strategic & Operational Contributions
- Support long-range resource planning and budgeting activities.
- Act as a subject matter expert in device technology internally and externally.
Key Relationships
- Internal device development specialists (HF, design, industrialisation, engineering, science)
- Formulation and product development teams
- Quality Assurance & Regulatory teams
- Manufacturing and technical operations teams
Education, Skills & Experience
Required
- Degree, HND, or equivalent in engineering or a technical discipline
- 8–10+ years’ experience in medical device or combination product development
- Demonstrated experience leading multidisciplinary project teams
- Strong knowledge of device design, control, and global regulatory frameworks & Working knowledge of ISO 13485, ISO 14971, ISO 62366, GMP
- Proven experience taking products from concept through commercialisation & Excellent communication and stakeholder management skills
- Practical, analytical and hands-on approach to device development
Preferred
- Experience with injection moulding / Experience with automated assembly or test equipment
- Prior expertise with drug delivery devices or needle-based injection systems
Device Development Lead in Cambridge employer: Next Phase Recruitment Limited
Contact Detail:
Next Phase Recruitment Limited Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land Device Development Lead in Cambridge
✨Tip Number 1
Network like a pro! Reach out to your connections in the medical device industry and let them know you're on the hunt for a Device Development Lead role. You never know who might have the inside scoop on job openings or can put in a good word for you.
✨Tip Number 2
Prepare for interviews by brushing up on your knowledge of regulatory frameworks and design control principles. Be ready to discuss how you've led multidisciplinary teams and managed projects from concept to commercialisation. Show us your hands-on approach!
✨Tip Number 3
Don’t just apply anywhere; focus on companies that align with your values and expertise in medical devices. Use our website to find roles that excite you, and tailor your approach to each company’s culture and mission.
✨Tip Number 4
Follow up after interviews! A quick thank-you email can go a long way in keeping you top of mind. Mention something specific from your conversation to show your genuine interest in the role and the company.
We think you need these skills to ace Device Development Lead in Cambridge
Some tips for your application 🫡
Tailor Your CV: Make sure your CV is tailored to the Device Development Lead role. Highlight your experience in medical device development and project leadership, and don’t forget to mention any relevant regulatory knowledge. We want to see how your background aligns with what we’re looking for!
Craft a Compelling Cover Letter: Your cover letter is your chance to shine! Use it to tell us why you’re passionate about device development and how your skills can contribute to our team. Be specific about your achievements and experiences that relate to the key responsibilities outlined in the job description.
Showcase Your Team Leadership Skills: Since this role involves leading multidisciplinary teams, make sure to highlight your leadership experience. Share examples of how you've successfully managed projects and collaborated with different teams. We love seeing how you’ve driven successful outcomes in your previous roles!
Apply Through Our Website: We encourage you to apply through our website for a smoother application process. It’s the best way for us to receive your application and ensures you’re considered for the Device Development Lead position. Plus, it shows you’re keen on joining our team!
How to prepare for a job interview at Next Phase Recruitment Limited
✨Know Your Stuff
Make sure you brush up on your knowledge of medical device development and the specific regulations like ISO 13485 and ISO 14971. Being able to discuss these frameworks confidently will show that you're not just familiar with the theory but can apply it practically.
✨Showcase Your Leadership Skills
Since this role involves leading multidisciplinary teams, be prepared to share examples of how you've successfully managed projects in the past. Highlight your experience in coordinating with different teams and how you ensured project timelines and quality were met.
✨Prepare for Technical Questions
Expect questions about the technical aspects of device development, including risk management and design control principles. Think of specific challenges you've faced and how you overcame them, as this will demonstrate your hands-on approach and problem-solving skills.
✨Engage with Human Factors
Given the importance of usability in device development, be ready to discuss your experience with human factors studies. Share insights on how you've defined performance requirements and tested devices to ensure they meet user needs effectively.