Instrument Development Engineer

About the role

This position is part of the University of Utah team in the ARPA-H Genetic Medicines and Individualized Manufacturing for Everyone (GIVE) program, which aims to make individualized RNA-based genetic medicines on demand. Our team is developing an all-in-one testing platform for full quality control testing and lot release within as little as one day. More information: https://arpa-h.gov/news-and-events/arpa-h-selects-teams-make-made-order-genetic-medicine-manufacturing-possible.

Develop and optimize biomedical devices, systems, or processes to enhance patient care and medical outcomes. Collaborate with interdisciplinary teams to innovate and refine medical technologies while ensuring adherence to regulatory and safety standards. Conduct risk analyses and implement measures to address potential hazards, prioritizing the well-being of patients and end-users. Uphold ethical practices and promote the advancement of reliable, safe biomedical technologies. May perform clinical and preclinical assessments. Typically requires a bachelor's degree in engineering, mathematics, or related scientific field.

Responsibilities

• Development of unmet needs / voice of the customer requirements / design inputs
• Ideation and concept development
• Development of designs / specifications / test methods / processes / manufacturing methods
• Test protocol development, benchtop / in vitro / in vivo testing, and report writing
• Employing analytic methods to evaluate concepts and designs
• Ensuring thorough and compliant design documentation
• Conducting risk analyses per applicable standards
• Conducting biomedical product / process / system / prior art benchmarking
• Developing cost of goods or cost of service models
• Participating in design review meetings
• Support regulatory approval processes and submissions
• Working with cross functional project teams, including physicians, researchers, manufacturers, and other related experts or project partners
• Contributing to new intellectual property via lab notebook documentation, invention disclosures, reduction to practice, and patent application reviews

Qualifications

EQUIVALENCY STATEMENT: 1 year of higher education can be substituted for 1 year of directly related work experience (Example: bachelor's degree = 4 years of directly related work experience).

The department may hire at one of the following levels:

• Biomedical Engineer II – Requires a bachelor's (or equivalency) + 4 years or a master's (or equivalency) + 2 years of directly related work experience. Developing-Level position in the General Professional track. Requires moderate skill set and proficiency in discipline. Conducts work assignments of increasing complexity, under moderate supervision with some latitude for independent judgment.
• Biomedical Engineer III – Requires a bachelor's (or equivalency) + 6 years or a master's (or equivalency) + 4 years of directly related work experience. Career-Level position in the General Professional track. Considered highly skilled and proficient in discipline. Conducts complex, important work under minimal supervision and with wide latitude for independent judgment.
• Biomedical Engineer IV – Requires a bachelor's (or equivalency) + 8 years or a master's (or equivalency) + 6 years of directly related work experience. Advanced-Level position in the General Professional track. Recognized as subject matter expert and advanced individual contributor professional. Requires specialized skill set. Conducts highly complex work, unsupervised and with extensive latitude for independent judgment.
• Biomedical