Biocompatibility Specialist I

Why Merit?

At Merit Medical, our mission is to create innovative medical devices that improve lives. Our goal is to hire and develop people who want to build something special through hard work, team effort, and commitment. Together, we are making a difference in the lives of patients around the world.

WORK SHIFT

SUMMARY OF DUTIES

ESSENTIAL FUNCTIONS PERFORMED

1. Performs biocompatibility safety assessments.
2. Analyzes biocompatibility test results.
3. Coordinates with cross-functional teams.
4. Develops biocompatibility assessment strategy plans.
5. Maintains working knowledge of applicable external standards.
6. Participates in continuous education.
7. Coordinates testing at contract laboratories.
8. Prepares biocompatibility documentation for 510k's, MDRs, and global markets.
9. Prepares responses to regulatory bodies.
10. Performs gap assessments of existing products.
11. Prepares Master Biological Safety Assessments.
12. Performs other duties and tasks, as required.

ESSENTIAL PHYSICAL/ENVIRONMENTAL DEMANDS

* Lifting -- Not to exceed 50 lbs. -- local practice may apply.
* Writing
* Sitting
* Standing
* Bending
* Visual acuity
* Color perception
* Depth perception
* Reading
* Field of vision/peripheral

SUMMARY OF MINIMUM QUALIFICATIONS

* Education and/or experience equivalent to a bachelor's degree in biomedical engineering, biology, microbiology, chemistry, biochemistry, toxicology, immunology, or related engineering or scientific discipline.
* Minimum of three years of related experience, which may include conducting biocompatibility assessments, health-based risk assessments, and chemical characterization analysis.
o BS: 3 years
o MS: 1 year
o PhD: 0 years
* Proficiency with ISO 10993 Biocompatibility standard series and FDA Guidance Document: Use of ISO 10993, and how that knowledge can be used to define biocompatibility test plans.
* Capacity to write rationales that are scientifically based, with scientific literature references when required.
* Excellent writing skills.
* Must have a basic scientific knowledge of biomaterials.
* Self-motivated, self-directing, strong attention to detail and excellent time management skills.
* Strong interpersonal skills and the ability to communicate well - verbally and in writing - with others.
* Ability to work well with people at all levels of the organization.
* Excellent analytical and problem-solving skills.
* Demonstrated computer skills preferably spreadsheets, word processing, database and other
applicable software programs.

COMPETENCIES

* Writing skills
* Computer skills
* Technical problem solving

COMMENTS

Infectious Control Risk Category II:

The risk category explains whether or not employees are likely to come into contact with blood or body fluids while performing their jobs. Risk category II states employment and procedures that may require exposure.

As an eligible Merit employee, you can expect the following:

* Multiple Shifts and Hours to choose from: Days, Swing (Eve), and Nights

* Medical/Dental & Other Insurances (eligible the first of month after 30 days)

* Low Cost Onsite Medical Clinic

* Two (2) Onsite Cafeterias

* Employee Garden | Gardening Classes

* 3 Weeks' Vacation | 1 Week Sick-Time | Paid Holidays

* 401K | Health Savings Account

To see more on our culture, go to www.merit.com/careers.

Military Veterans are encouraged to Apply.

Merit is a proud Utah Patriot Partner committed to hiring our Veterans.