Senior Polymer Component Development Engineer
Our client, a medical device company developing a new and innovative device to support the heart, is currently seeking a Senior Polymer Development Engineer to join their team. Reporting to the R&D Manager, the Senior Polymer Component Development Engineer will be an experienced engineer with intimate knowledge of thin film polymer processing. The key responsibility will be the development and optimization of one of the company's core technology components. The Senior Polymer Component Development Engineer will be responsible for the development and ultimately manufacturing of thin film polymer components as well as their assembly and integration into the final device. The Senior Engineer, Polymer Processing, will work closely with counterparts responsible for catheter development and device characterization. The Polymer Engineer will have hands-on knowledge and experience in the development of cardiovascular devices.
Role/Responsibilities Design and development of polymer components and specification of polymer materials/formulations to achieve required functional & mechanical performance.Develop processes and work instructions for the manufacturing of proprietary polymer components in the company's catheter device.Develop and maintain the polymer processing manufacturing environment.Ensure good communication with peers and management in the continuous feedback loop between device design, design characterization, and manufacturing processes.Develop test methods and protocols for design verification testing of the polymer component.Anticipate risks and challenges; proactively ensure availability of adequate mitigation plans.Ensure adequate IP generation to protect novel developments and findings.Manage relationships with third-party development and manufacturing vendors.Skills, Qualifications & Experience Either a primary degree or Master's Degree in a relevant engineering discipline such as polymer, mechanical, biomaterials, or biomedical engineering, or equivalent experience.Experience in medical device GMP and compliance to ISO 13485.Familiarity with statistical analysis techniques and DOE.Experience in equipment specification, design, and qualification.Competency in Solidworks or equivalent 3D CAD system.Self-directed engineer with entrepreneurial drive.Have an established vendor network relevant to the device development.Experience with creation and processing of thin polymer films, in particular biocompatible elastomers.Experience with creation of thin film polymer 3D shapes.Experience with bonding of thin film polymer layers.Excellent communication skills in English.
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