Micro Catheter Engineering and Operations Manager
Performs the transitions of Prototype and Experimental equipment to full scale production equipment, staffing and establishment of Methods, Documentation and Quality Systems necessary to commercialize medical devices.
Responsibilities:
Develop,document and implement Q/A, Regulatory and Compliance Systems required to transition developmental equipment and processes into GMP and ISO compliant operations for state of the art minimally invasive micro catheters.
Perform day to day management/documentation of Catheter Production. This includes direct supervision of production staff, specification and purchasing of materials, and ensuring compliance to appropriate regulatory bodies and quality standards.
Design and Conduct Validation studies with the assistance of Staff and Regulatory Consultants for ongoing Catheter Production.
As necessary, performs other duties as required.
Education:
BSME, BSIE, BSCHE – Desired but not necessary.
Post education in Regulatory, Standards and Quality systems a plus.
Knowledge and Experience:
Must have some level of experience with direct supervision and/or management of production personnel.
Requires knowledge of Regulatory requirements for Medical Device Product Launch.
Requires a working knowledge of statistical sampling methods.
Requires knowledge of Medical Industry Test Methods and requirements.
Requires knowledge of PC based software (MS Word, XCEL, Power Point).
Requires at least a minimal knowledge of Autocad and Solid Works.
Requires a working knowledge of Polymers (primarily Nylon based thermoplastics).
Requires a working knowledge of Metals (Primarily Stainless Steel).
Requires a working knowledge of FDA and ISO standards directly related to the development and sales of Medical Devices.
Requires a working knowledge of Quality Standards and Methods
Skills and Abilities:
Ability to organize and prioritize workflow
Ability to interact with all levels of employees including senior management
Strong attention to details
Ability to work independently and with little supervision
Ability to perform mathematical calculations or analysis
Ability to adhere/respond to established time frames and schedules
Ability to operate a computer and related software
Good communication skills
Problem Solving and Decision Making:
Very Important to have demonstrated problem solving and decision making.
Physical Requirements:
Requires good dexterity in both hands. This job will involve the fabrication and handling of delicate instruments and micro catheters (roughly 0.020” in diameter)
Requires vision capability necessary to observe through a micro scope
Ability to lift and stack items up to 50 lb in weight
Supervisory Responsibility:
Will have direct supervisory responsibilities over production staff between 2 and 25.
Travel Requirements:
Minor Travel to coordinate with vendors and with parent company in California
Travel required to various customer and vendor locations.
Interested candidates should apply online at:
http://www.volcanocorp.com/careers/available-positions.asp
EEO/AA M/F/V/D
