We are looking for a highly skilled Lead Engineer - Device Development to join our team and play a critical role in the design and development of cutting-edge smart inhalation systems. This position is pivotal in ensuring that our medical devices meet the highest quality standards and regulatory requirements, from design conception through to verification and validation. You will lead the translation of design input requirements into detailed design specifications, guiding the process from concept to functional prototypes.
Key Responsibilities:
1. Development of Technology Concepts:
1. Problem Analysis: Conduct detailed situation and problem analysis to understand and define the needs of the medical device development.
2. Solution Proposals: Develop and propose innovative solutions for technical challenges in medical devices, specifically nebulisers.
3. Feasibility Studies: Plan, implement, and document feasibility studies to assess potential solutions and their effectiveness.
2. Technical Implementation into Device Design:
1. Component Requirements: Define and specify the requirements for device components, ensuring the selection of high-quality and suitable materials.
2. Supplier Coordination: Communicate and collaborate with component suppliers to ensure the timely and accurate delivery of necessary parts.
3. Simulation & Analysis: Conduct simulations to analyze device functions, such as component life cycles and performance parameters, to optimize the design.
4. Prototype Development: Oversee the development and manufacturing of functional samples and prototypes, ensuring they meet design expectations.
5. Testing & Optimization: Lead the testing and iterative optimization of functional prototypes, refining them to meet performance and regulatory standards.
3. Design Testing & Verification:
1. Design Proof: Plan and execute design proof, ensuring that the device meets all functional and safety requirements.
2. Verification & Validation: Develop verification and validation plans and protocols, using both technical specifications and experience from clinical trials and standard applications.
3. Test Reporting: Document test results, report findings, and manage corrective actions where necessary.
4. Software Validation Support: Collaborate with the software team to support the validation of device software, ensuring it operates effectively with the hardware.
Qualifications:
1. Bachelor’s or Master’s degree in Engineering, Mechanical Engineering, or a related field.
2. 5 years of experience in medical device development, particularly in device design and verification.
3. Very good knowledge of fluid mechanics, mechanics, manufacturing technology, plastics technology, prototyping.
4. Strong understanding of design controls, product development processes, and regulatory standards for medical devices.
5. Excellent communication skills, with the ability to collaborate with multidisciplinary teams and external suppliers.
6. Experience with component selection, supplier management, and device simulations.
What We Offer:
1. Competitive salary and benefits package.
2. The opportunity to work on innovative medical device technologies that improve patient outcomes.
3. A collaborative, fast-paced work environment with opportunities for professional development.
If you are passionate about driving the development of life-saving medical technologies and have the technical expertise to guide projects from concept to completion, we encourage you to apply.
205 Cambridge Science Park
Milton Road
Milton
Cambridge
CB4 0GZ
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