What are the responsibilities and job description for the R&D Engineer II position at Trisalus Life Sciences, Inc.?
Duties and Responsibilities: Assist in the development of new products from concept generation through commercialization using design and development systems in accordance with FDA and international regulations.
Work independently to plan, execute, and document small projects and/or portions of larger projects.
Collaborate with interdisciplinary teams, including quality assurance, regulatory affairs, and manufacturing, to ensure smooth transition from product concept to production.
Design, build and test functional prototypes to demonstrate proof of concept in bench testing and animal studies.
Lead design verification and validation activities, including planning, manufacturing and generating test protocols and test reports.
Develop, qualify and validate new manufacturing processes and/or test methods.
Assist in and/or lead the preparation and review of technical documents, including design inputs, risk management documents, test protocols, and reports.
Interact with marketing department and customers (ie, physicians) to identify and document new product requirements according to user and clinical needs.
Manage activities with outside vendors that provide components, assemblies, manufacturing processes, testing, and other services.
Prepare and maintain detailed design and process documentation in accordance with internal procedures and U.S. and international regulatory requirements
Stay current with the latest developments in the clinical field and contribute innovative ideas for new products or improvements to existing products.
Qualifications
Education & Certifications:
Bachelor’s degree in mechanical engineering, Biomedical Engineering, or related field.
Work Experience:
2-5 years’ experience in a medical device R&D environment is required.
Basic understanding of FDA regulations and ISO standards related to medical device development is preferred
Knowledge, Skills & Abilities:
Able to read, write and understand English.
Proven problem-solving abilities, analytical thinking and attention to detail.
Proficiency in 3D CAD software, such as SolidWorks or AutoCAD.
Experience with design controls and risk management within a regulated industry is a plus.
Physical Requirements:
Must be able to work in an office and lab/cleanroom environment. Some travel may be required for vendor visits or conferences.
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