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
* Conduct R&D activities to improve the polymer-based device formulation to meet the desired properties and medical device specification.
* 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.
* Support efforts in scaling up polymer-based processes from laboratory to pilot-scale production, ensuring seamless transition and efficiency.
* Design, optimize, and validate new testing protocols.
* Maintenance and qualification of laboratory equipment
* Maintain comprehensive records, including experimental data, observations, and outcomes, following strict documentation protocols and QA/RA Requirements
* Contribute actively to the implementation and improvement of H&S requirements.
* Produce weekly reports on progress.
* Create and manage the design history files and technical files for the product.
* Support product regulatory submissions.
Qualifications
* A master’s degree in Organic Chemistry or Chemical Engineering with a background in Polymer Science
* At least 4-5 years proven industrial experience in a production or manufacturing and characterisation, in roles directly related to polymer science.
* Demonstrated expertise in polymer characterisation, processing, and synthesis techniques.
* Experience in working with hydrogels.
* Previous experience within an R&D Laboratory or materials development environment
* Experience in experimental design and proficient data analysis skills.
* Excellent written and oral communication skills
* The ability to handle priorities effectively to meet deadlines under pressure through effective time management.
* Self-motivated and capable of working with minimum supervision.
* Be able to meet the challenges of a fast-paced start-up and provide innovative ideas to the technical team.
Desirable
* Working knowledge of Medical Device Quality Management System (ISO 13485).
* Experience in creating documentation for regulatory compliance (for example: FDA, CE, etc)
* Experience with design reviews and design controls.
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