Job Description

University of Utah Job Description

Job Summary

Conceptualizes, designs, prototypes, tests and develops for actual use, improved and innovative biomedical devices, processes or systems.

Qualifications

Bachelor’s Degree in Mechanical Engineering, Biomedical Engineering, or related field plus 6 years related experience or equivalency (one year of education can be substituted for two years of related work experience) required. Other qualifications include:

• One or more successes bringing biomedical devices, processes or systems from concept to actual use
• Proficient in CAD model and drawing creation
• Proficient in design verification and validation activities
• Knowledgeable in applicable anatomy and physiology
• Expertise in at least one clinical area
• Expertise in at least one biomedical product / process / system area
• Effective in applying engineering science and technology knowledge
• Effective use of statistical methods
• Efficient in the management of resources
• Strong written and oral communication skills
• Strong project management skills
• Experience contributing to new intellectual property
• Knowledgeable with applicable regulatory and quality requirements (e.g., FDA 21 CFR 820 and ISO 13485)
• Flexibility, persistence, resourcefulness, and a drive to succeed

Applicants must demonstrate the potential ability to perform the essential functions of the job as outlined in the position description.

Disclaimer

This job description has been designed to indicate the general nature and level of work performed by employees within this classification.  It is not designed to contain or be interpreted as a comprehensive inventory of all duties, responsibilities and qualifications required of employees assigned to the job.

Essential Functions

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

Problem Solving

Assignments are defined in terms of general objectives and are of moderate scope and moderate technical complexity.  May assign work to lower level technical support employees. Relies on experience and sound judgment to plan and accomplish goals.

Comments

Work Environment and Level of Frequency typically required

Nearly Continuously: Office environment.

Physical Requirements and Level of Frequency that may be required

Nearly Continuously: Sitting, hearing, listening, talking.

Often: Repetitive hand motion (such as typing), walking. 

Seldom: Bending, reaching overhead.