R&D Engineer
Trisalus Life Sciences, Inc.
Westminster, CO, US
Full-time
Job Description
Job Description
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.
- 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 :
- 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.
- Location : Westminster, Colorado
Print Employee Name :
Employee signature : Date :
Supervisor : Date :
30+ days ago