Job Description

University of Utah Job Description

Job Summary

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

Qualifications

Bachelor’s Degree in Mechanical Engineering, Biomedical Engineering, or related field plus 10 years’ experience or equivalency required. Other qualifications include:

• Multiple successes bringing biomedical devices, processes or systems from concept to actual use
• Highly proficient in CAD model and drawing creation
• Highly proficient in design verification and validation activities
• Expertise in applicable anatomy and physiology
• Expertise in multiple clinical areas
• Expertise in multiple biomedical product / process / system areas
• Highly proficient in applying engineering science and technology knowledge
• Proficient use of statistical methods
• Highly efficient in the management of resources
• Excellent written and oral communication skills
• Excellent project management skills
• Effective at contributing to new intellectual property
• Depth of knowledge 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 analytical 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 diverse scope and high technical complexity.  May assign work to lower level technical support employees. Relies on extensive 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.