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
