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R&D Engineer II - Westminster, United States - TriSalus Life Sciences
Description
TriSalus Life Sciences, Westminster, CO, US15 days ago
Requisition ID: 1090
Salary Range:
Job title:
R&D Engineer
Job Document #:
JOB-0078 R02
Department:
Research & Development
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.
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.
QualificationsEducation & Certifications:
Bachelor's degree in Mechanical Engineering, Biomedical Engineering, or related field.
Work Experience:
3-5 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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