Instrument Development Engineer

University of Utah

Salt Lake City (UT)

In loco

USD 60.000 - 100.000

Tempo pieno

14 giorni+

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Descrizione del lavoro

University of Utah is seeking an Instrument Development Engineer to join our ARPA-H GIVE program. You will help develop an all-in-one testing platform for rapid quality control and lot release, collaborating with clinicians, researchers, and partners to ensure safety and regulatory compliance.

You will design and optimize biomedical devices, conduct risk analyses, and contribute to IP generation and verification, with opportunities to influence next‑gen RNA‑based medicines.

Competenze

Bachelor's degree in engineering, mathematics, or related scientific field.
Experience designing and building instruments or devices.
Ability to conduct risk analyses and document design work.

Mansioni

Develop unmet needs and translate voice of the customer into design inputs.
Ideate, develop, and document designs, test methods, and manufacturing processes.
Create test protocols for benchtop, in vitro, and in vivo testing and write reports.
Perform risk analyses per applicable standards and support regulatory submissions.
Collaborate with physicians, researchers, manufacturers, and partners.

Conoscenze

Instrument design

Hardware testing

CAD

Bench debugging

Subsystem integration

Risk management

Python

Data analysis

Formazione

Bachelor's degree in engineering, mathematics, or related scientific field

Strumenti

CAD software

Lab data acquisition

Fabrication techniques

Descrizione del lavoro

Instrument Development Engineer

Job Summary

Biomedical Engineers

This position is part of the University of Utah team in the ARPA-HGenetic Medicines and Individualized Manufacturing for Everyone(GIVE) program, which aims to make individualized RNA-based geneticmedicines on demand. Our team is developing an all-in-one testingplatform for full quality control testing and lot release within aslittle 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 vivotesting, and report writing
Employing analytic methods to evaluate concepts anddesigns
Ensuring thorough and compliant design documentation
Conducting risk analyses per applicable standards
Conducting biomedical product / process / system / prior artbenchmarking
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, includingphysicians, researchers, manufacturers, and other related expertsor project partners
Contributing to new intellectual property via lab notebookdocumentation, invention disclosures, reduction to practice, andpatent application reviews

NOTE: All applicants must submit a cover letter describing one thing you built that had not existed before, and what you personally designed, built or tested in it.

Biomedical Engineer, II

Support biomedicalengineering projects by contributing to the design and evaluationof medical systems. Collaborate with teams to identify and addressperformance challenges while ensuring alignment with regulations.Build skills in delivering practical, safe, reliable, and complianthealthcare solutions that advance medical technologies. May performclinical and preclinical assessments. Typically requires abachelor's degree in engineering, mathematics, or relatedscientific field. Requires moderate skill set and proficiency indiscipline. Conducts work assignments of increasing complexity,under moderate supervision with some latitude for independentjudgment.Requires a bachelor's (or equivalency) + 4 years or a master's (or equivalency) + 2 years of directly related workexperience.This is a Developing-Level position in the GeneralProfessional track.

Biomedical Engineer, III

Develop and improvebiomedical systems to enhance patient care and safety,collaborating with teams to deliver effective and reliablesolutions. Support risk assessments and align projects withindustry standards. Contribute to the development of safe andinnovative healthcare technologies through precise anddetail-oriented engineering. May performclinical and preclinical assessments. Typically requires a bachelor's degree in engineering,mathematics, or related scientific field. Considered highly skilledand proficient in discipline. Conducts complex, important workunder minimal supervision and with wide latitude for independentjudgment.Requires a bachelor's (or equivalency) + 6 years or a master's (or equivalency) + 4 years of directly related workexperience.This is a Career-Level position in the GeneralProfessional track.

Biomedical Engineer, IV

Design and refinebiomedical devices and systems, focusing on quality, safety andeffectiveness. Contribute to multidisciplinary teams to meetregulatory and performance goals. Conduct evaluations to identifyimprovement opportunities, ensuring systems meet industrystandards. Advance healthcare technologies by combining innovativethinking with practical, standards-compliant engineering. Mayperform clinical and preclinical assessments. Typically requires abachelor's degree in engineering, mathematics, or relatedscientific field. Recognized as subject matter expert and advancedindividual contributor professional. Requires specialized skillset. Conducts highly complex work, unsupervised and with extensivelatitude for independent judgment.Requires a bachelor's (orequivalency) + 8 years or a master's (or equivalency) + 6 years ofdirectly related work experience.This is an Advanced-Level positionin the General Professional track.

Biomedical Engineer, V

Provide in-depth technicalexpertise in biomedical engineering, driving advancements inmedical technology design and performance. Evaluate systems forcompliance and reliability, contributing to enhanced safety andefficacy. Collaborate with multidisciplinary teams to refineprocesses and identify opportunities for innovation. Support theintegration of risk assessments to ensure robust and reliablesolutions. May perform clinical and preclinical assessments.Typically requires a bachelor's degree in engineering, mathematics,or related scientific field. Recognized as subject matter expertand advanced individual contributor professional. Requiresspecialized skill set. Conducts highly complex work, unsupervisedand with extensive latitude for independent judgment.Requires abachelor's (or equivalency) + 10 years or a master's (orequivalency) + 8 years of directly related work experience.This isan Expert-Level position in the General Professional track.

Minimum 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 workexperience).

Department may hire employee at one of the following joblevels:

Biomedical Engineer, II: Requires a bachelor's (orequivalency) + 4 years or a master's (or equivalency) + 2 years ofdirectly related work experience.

Biomedical Engineer, III: Requires a bachelor's(or equivalency) + 6 years or a master's (or equivalency) + 4 yearsof directly related work experience.

Biomedical Engineer, IV: Requires a bachelor's (orequivalency) + 8 years or a master's (or equivalency) + 6 years ofdirectly related work experience.

Biomedical Engineer, V: Requires a bachelor's (orequivalency) + 10 years or a master's (orequivalency) + 8 years ofdirectly related work experience.

Preferences

Preferred qualifications:

A record of designing and building instruments or devices that had not been built before.
Hands-on experience designing, building and testing hardware,including CAD, fabrication, assembly and bench debugging.
Experience integrating subsystems from several engineeringdisciplines into one working instrument.
Experience turning a research result or laboratory method into anautomated, engineered system that others can use.
Evidence of original research or development, such as lead-authorpublications or granted patents.
Experience performing risk management to ISO 14971, includinghazard identification, risk analysis and verification of riskcontrols.
Experience writing test protocols, and keeping records anddrawings under document control on a team project.
Depth in at least two of the following:
1. 1. Mechanical and electromechanical design, including motioncontrol, actuators, precision positioning, and automated handlingof samples or consumables.
2. 2. Electronics and embedded systems, including circuits forsensors, data acquisition and microcontroller firmware.
3. 3. Optical systems, including optical design and optomechanics,photodetector selection and low-light detection, andcharacterization of sensitivity and noise.
4. 4. Instrument control software, including device control,automation, and data acquisition and analysis in Python or asimilar language.
5. 5. Microfluidic device design and fabrication, including layout,bonding and sealing, fluid interfaces, and fabrication methodssuited to manufacture.