Currently I am 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