Cytori Therapeutics, Inc. is dedicated to developing and delivering innovative cell-based therapies to improve the quality and length of life. We are a global, public company engaged in the development and commercialization of stem and regenerative cell therapies for the treatment of cardiovascular disease, reconstructive surgery and many other serious, chronic, and life threatening conditions.
Performs design and development activities on electrical design of medical devices. Conducts product testing and creates Design Control documentation, prototypes, and models. May perform clinical and pre-clinical assessments. Operates under minor supervision.
ESSENTIAL DUTIES AND RESPONSIBILITIES include the following. Other duties may be assigned.
Qualifies and debugs hardware and circuits.
Creates prototypes and pilot devices with schematic diagrams and PCB layouts.
Collaborate on product specifications and component selection.
Assists in developing programs on embedded controllers for prototype and pilot devices.
Serves as key team member in Development project coordination and project Design Control efforts.
Helps produce documents for electrical product risk management system, including plans, hazard analysis and FMEA / FMECA.
Development and documentation of protocols, procedures, and work instructions.
Performs medical device product design and testing activities.
Participates in product design meetings.
Prepares reports of results and conclusions.
May serve as liaison to outside vendors and contractors.
Ensures that vendors and contractors have the abilities and resources to support development.
To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
5+ years experience with schematic capture, PCB layout, and SPICE simulations.
5+ years experience with digital electronics design including knowledge of:
Basic Computer Architecture
Serial Communications Protocols
5+ years experience with analog electronics design including knowledge of:
Relays, Diodes, and Transistors
Voltage Regulation and Power Distribution
2-4 years experience with electrical test fixtures and soldering.
2-4 years experience with Real-Time Operating System preferred (ARM architecture processor experience a plus).
Experience with C and/or C++ Programming a plus.
Experience with SVN, Git, or equivalent code revision program and embedded systems programming a plus.
Knowledge of quality system principles; FDA Quality System Regulation (cGMP); ISO 9001 / 13485 quality system standards; requirements for product development in a regulated environment, including design control, hazard analysis, validation, and process metrics.
Knowledge of ISO14971 Risk Management Systems.
Ability to work with development engineers and other functional group personnel to accomplish common goals.
Detail oriented, with good written and verbal English communication skills.
Skilled in word processing, spreadsheets, and databases.
EDUCATION and/or EXPERIENCE
Bachelor's degree in engineering required; may have advanced degree. A minimum of 5 – 10 years of medical device engineering experience preferred.
SYSTEMS TECHNOLOGY SKILLS
Knowledge in utilization of Microsoft Word, Excel, Outlook, PowerPoint; OrCAD or equivalent schematic capture program; PADS or equivalent PCB layout program; SVN, Git, or equivalent code revision program a plus; and embedded systems programming IDE a plus.
The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
While performing the duties of this job, the employee is regularly required to talk or hear. The employee frequently is required to stand, walk, bend, and sit. Specific vision abilities required by this job include close vision, distance vision, and ability to adjust focus. The employee must have the manual dexterity and manual ability to effectively use computer terminals and keyboards/input devices. Occasional travel may be required.
The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.