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TriSalus Life Sciences
Westminster, CO | Full Time
$107k-137k (estimate)
1 Week Ago
TriSalus Life Sciences
Westminster, CO | Full Time
$106k-135k (estimate)
1 Week Ago
R&D Engineer
TriSalus Life Sciences Westminster, CO
$107k-137k (estimate)
Full Time | Medical Technology 1 Week Ago
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TriSalus Life Sciences is Hiring a R&D Engineer Near Westminster, CO

 

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

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Job Summary

JOB TYPE

Full Time

INDUSTRY

Medical Technology

SALARY

$107k-137k (estimate)

POST DATE

05/11/2024

EXPIRATION DATE

07/19/2024

WEBSITE

trisaluslifesci.com

HEADQUARTERS

Westminster, CO

SIZE

50 - 100

INDUSTRY

Medical Technology

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TriSalus Life Sciences
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