SUMMARY OF DUTIES
Performs routine biocompatibility related tasks and assists with developing test strategies and plans.
ESSENTIAL FUNCTIONS PERFORMED
Assists with developing test strategies and test plans for biomaterials used in Merit products.
Consults with project teams on material choices, analysis and development.
Assists with writing biocompatibility sections of 510(k)s, PMAs, IDEs, etc. for regulatory submissions, both in the U.S. and global markets.
Assists with writing no-test rationales for well-known and understood biomaterials.
Works with R&D teams and engineers.
Works with other staff in resolving biomaterial and technical problems.
Writes risk/benefit analyses when necessary.
Performs other tasks, as needed.
ESSENTIAL PHYSICAL/ENVIRONMENTAL DEMANDS
Lifting - Not to exceed 50 lbs. - local practice may apply.
Field of vision/peripheral
Fine motor skills
SUMMARY OF MINIMUM QUALIFICATIONS
Education and/or experience equivalent to a Bachelor's Degree in Biomedical Engineering or related field with focus in biomaterials/chemistry.
A minimum of one year of related experience, which may include conducting biocompatibility assessments, health-based risk assessments and chemical characterization analysis.
Familiarity 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 assist writing rationales that are scientifically based, with scientific literature references when required.
Excellent writing skills.
Must have scientist 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.
Technical problem solving
Merit Medical Systems, Inc., an Equal Opportunity Employer M/F/D/V, is a dynamic, progressive and innovative company with a strong global presence. Our culture is highly energetic, family friendly, values its employees, and promotes them as standard business practice. Merit currently has an opening at its corporate headquarters in South Jordan, Utah in our Operational Systems Department. Excellent compensation and benefits packages will be offered to the right candidate.
Merit Medical Systems, Inc. (NASDAQ, MMSI) was founded in 1987 by Fred P. Lampropoulos. Merit develops, manufactures and markets single-use medical devices primarily for diagnosing and treating cardiovascular and vascular disease. Merit has been successful in introducing and marketing innovative, high-quality products through its expertise in new product design and its capabilities in injection and insert molding of plastics; the application of its proprietary electronic and sensor-based technologies; and wire, extrusion and catheter technologies. The Company is utilizing its competitive advantages and technologies to develop and offer products that address a wide range of needs related to cardiology and radiology procedures performed in hospitals. Sales are made primarily to U.S. hospitals through a direct sales force. The Company markets its products in over 60 countries worldwide, utilizing a direct sales force in Europe, and distributors for the remainder of the world.
MERIT MEDICAL SYSTEMS, INC.
1600 West Merit Parkway South Jordan, UT 84095