LennTech Search are delighted to be assisting a medical device company recruit a Medical Device Engineer to join an exciting team in growth mode.

The company is seeking a highly skilled Medical Device Engineer with a strong background in polymer chemistry. As a vital member of our team, you will play an essential role in the development, production and testing of our innovative medical device.

Key Responsibilities

1. Conduct R&D activities to improve the polymer-based device formulation to meet the desired properties and medical device specification.
2. Utilise in-depth knowledge of polymer science to design, optimise and develop production processes, ensuring efficiency and quality in the manufacturing of polymer-based materials.
3. Support efforts in scaling up polymer-based processes from laboratory to pilot-scale production, ensuring seamless transition and efficiency.
4. Design, optimize, and validate new testing protocols.
5. Maintenance and qualification of laboratory equipment.
6. Maintain comprehensive records, including experimental data, observations, and outcomes, following strict documentation protocols and QA/RA Requirements.
7. Contribute actively to the implementation and improvement of H&S requirements.
8. Produce weekly reports on progress.
9. Create and manage the design history files and technical files for the product.
10. Support product regulatory submissions.

Qualifications

1. A master’s degree in Organic Chemistry or Chemical Engineering with a background in Polymer Science.
2. At least 4-5 years proven industrial experience in a production or manufacturing and characterisation, in roles directly related to polymer science.
3. Demonstrated expertise in polymer characterisation, processing, and synthesis techniques.
4. Experience in working with hydrogels.
5. Previous experience within an R&D Laboratory or materials development environment.
6. Experience in experimental design and proficient data analysis skills.
7. Excellent written and oral communication skills.
8. The ability to handle priorities effectively to meet deadlines under pressure through effective time management.
9. Self-motivated and capable of working with minimum supervision.
10. Be able to meet the challenges of a fast-paced start-up and provide innovative ideas to the technical team.

Desirable

1. Working knowledge of Medical Device Quality Management System (ISO 13485).
2. Experience in creating documentation for regulatory compliance (for example: FDA, CE, etc).
3. Experience with design reviews and design controls.

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