Scope of Duties / Job Description:

Develop systems and procedures designed to maintain compliance with the Quality System.
Balloon Catheters, Braided Catheters, and/or Electrophysiology Catheters experience preferred
Prototyping and supplier management a must
Hands on catheter prototyping experience required
Knowledge of braiding, extrusions, polymers, and catheter assembly process required
Work with R&D on to develop product specifications, processes, and prototypes
Work with Sales and Marketing to establish correct and complete user needs
Ensure product requirements are met through specifications in the design control process
Work with Manufacturing Engineering on product/process improvement projects
Define a verification/validation process and develop written protocols in conjunction with appropriate functions;
To oversee and/or perform testing and analyses in support of new products or changes to existing products
Develop, implement and maintain inspection and test methods for finished products and in-coming components and materials. Evaluate precision and accuracy of test methods, measurement equipment and production equipment
Interpret engineering drawings, schematic diagrams, or formulas and confer with engineering staff to determine quality and reliability standards
Develop and analyze statistical data and product specifications to determine present standards and establish proposed quality expectancy of finished product. Recommend modifications of existing products, materials, or components to achieve the established quality standards and overall reliability standards
Perform inspection and testing of the products as assigned. Review and approve the Device History Record
Develop and provide presentations and reports to product and/or executive management on the current status of projects
Other duties as assigned

Education / Training:

BS or MS in Mechanical Engineering or related degree preferred. Minimum of 1 years of engineering experience.
1-3 years direct experience with developing catheters
3 years minimum of Medical Device experience, including yield improvement and component outsourcing efforts.
Salary depends on experience

Other Requirements:

Knowledge of Good Manufacturing Practices (GMP) and applicable Quality System Standards.
SOLDWORKS proficiency required.
Drawing and GD&T proficiency required.
Excellent verbal and written communication skills are required.
Medical device Design controls knowledge required
Disposable Class II and Class II medical device experience preferred.
Stents, guidewires, and catheter experience preferred.
Demonstrated proficiency utilizing problem solving tools (i.e., FMEA, DOE, SPC, etc.) and application of statistical techniques is desired.
Must be proficient with MS Office Package.
Familiarity with the sterilization methods and biocompatibility testing is a plus
Ability to perform activities to support product development, administration, manufacturing, and other company activities

Job Type: Full-time

Pay: From $70,000.00 per year

Benefits:

401(k)
Dental insurance
Health insurance
Paid time off
Retirement plan
Vision insurance

Schedule:

8 hour shift
Monday to Friday

Work Location: In person

Nventric, Inc.

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