| Requisition Number: | 12-579 |
| Job Title: | Principal Medical Device Development Engineer |
| Area of Interest: | Research & Development |
| Shift: | 1st |
| Position Type: | Full Time - Regular |
| Percentage of Travel Required: | 10% - 25% |
| City: | Rancho Cordova |
| State/Province: | California |
| Country: | U.S. |
| Job Summary: | Volcano Corporation is dedicated to developing breakthrough technologies that save people's lives and enhance their current quality of life! At Volcano you will find a pioneering and innovative spirit with a wide range of opportunities.
Without the exceptional professionals at Volcano Corporation, we simply could not fulfill our mission to improve the lives of patients worldwide. DUTIES AND RESPONSIBILITIES:
The successful candidate in this position will provide technical expertise to the design and development of new FL.IVUS catheter products. Investigate/evaluate existing technology and advise R&D, Regulatory Affairs, and Reliability Engineering to ensure appropriate process development under the best possible conditions. Design and implement new methodologies, materials, machines, processes, or products. Develop new concepts from initial design to market release. Conduct feasibility studies of the design to determine ability to function as intended. Maintain detailed documentation throughout all phases of R&D. Coordinates activities with outside supplier and consultants to ensure the delivery of supplies or services needed to meet scheduled time lines.
This is an individual contributor position, as such, the candidate will need to be hands on, a self-starter, and work with moderate supervision. This position will also be responsible for leading the engineering team in pursuit of design/development of product goal initiatives
- Develop new disposable device designs and optimize existing designs. Fabricates prototype devices.
- Design and develop new processes and tooling for device fabrication and manufacture.
- Coordinates verification and validation activities such as writing plans and reports fabricating devices and supervising technicians.
- Transfers new designs from research and development into production. Oversees the writing of work instructions and training of operators. Assists with development preventative maintenance schedules.
- Documents components, designs, processes and tools.
- Maintains laboratory equipment, notebook and current training record.
- Performs other duties as required.
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| Qualifications: | MINIMUM QUALIFICATIONS, KNOWLEDGE, SKILLS AND ABILITIES:EDUCATION:
- Bachelor's degree in Materials Science, Plastics Engineering or Mechanical Engineering, or equivalent training.
KNOWLEDGE AND EXPERIENCE:
- 8+ years of focused catheter development experience (preferred) or 12 years equivalent product development experience in other FDA regulated environments.
- Demonstrated strong Solidworks experience or other design software tools.
- Extensive practical experience designing plastic components and assembly processes using a range of polymeric based materials; such as Nylon 12, Pebax and co-polyester Elastomers, Polyolefins, and engineering plastics like polyimide, PEEK and PTFE.
- Demonstrated knowledge of major polymer processing techniques, including extrusion, blow molding, balloon blowing, injection molding, and thermoforming operations.
- Practical experience with adhesive chemistry and processing methods.
- Practical understanding of variation statistics (ANOVA), Design of Experiments (DOE), process validation and design control.
- Practical exposure to Project Management Tools. The successful candidate will demonstrate successful completion of a cradle to grave project, including document control requirements for project phases.
- Knowledge of Microsoft Office Products and other computer applications (i.e.: Word, Excel, PowerPoint & Project, Windows, Visio, and Statistical Software: Minitab, JMP, etc.)
- Knowledge of proper English usage, grammar, spelling, vocabulary and of generally accepted office practices, procedures and equipment
SKILLS AND ABILITIES:
- Ability to work with external material and engineering vendors.
- Ability to communicate effectively, both oral and written, in order to establish and maintain cooperative working relationships with persons contacted in the course of performing assigned duties including Company management and outside business associates
- Ability to exercise independent judgment consistent with department guidelines
- Ability to organize and prioritize workflow and to meet established timeframes
- Ability to maintain up-to-date knowledge of procedures, products and activities of assigned area
PROBLEM SOLVING AND DECISION MAKING:
- Ability to assess a problem quickly and determine to what level it should be elevated, directing staff/customers to the correct person(s).
- Effective use of problem solving tools.
PHYSICAL REQUIREMENTS:
- Ability to hear and speak to employees and outside business associates on the phone and in person
- Ability to see the letters and numbers on a personal computer screen and on memos, reports and other documents (near vision)
- Ability to consistently work using a high powered microscope
- Requires good manual dexterity for the assembly of small plastic components and use of personal computer
SUPERVISORY RESPONSIBILITY:
- May oversee Intermediate Engineers and/or Engineering Technicians
TRAVEL REQUIREMENTS:
- Ability to travel up to 25% (domestic and international locations).
Headquartered in Sacramento, CA, Volcano maintains expansive facilities housing engineering, laboratory, manufacturing and production operations in Northern California and various locations worldwide. These positions are located at our Sacramento, CA location which is less than two hours away from the San Francisco bay area, Lake Tahoe, snow skiing, the wine country and the Northern California beaches.
Volcano is an Equal Opportunity Employer. It is the policy of Volcano Corporation, to base all employment decisions on the principles of equal employment opportunity and to take affirmative action in the employment of women, minorities, individuals with disabilities, and veterans. |
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