Pro-Dex, Inc. headquartered in Santa Ana California, a publicly traded (NASDAQ symbol: PDEX) profitable and expanding engineering development and manufacturing company. Pro-Dex specializes in bringing speed to market in the development and manufacture of technology-based solutions that incorporate embedded motion control and miniature rotary drive systems serving the medical, dental, factory automation and scientific research markets.
We currently have an immediate opportunity for an experienced Vice President of Engineering Research and Development to join our team at our Santa Ana, California location.
Senior product development executive responsible for directing the design and development of products aimed at bringing new products to the marketplace. Will provide strategic and tactical direction for engineering research and development across multiple complex device platforms including medical device technologies as well as product development. The scope of responsibility will bridge the continuum from product concept through design review phases, and manufacturing and ultimate release to Manufacturing. This individual will be responsible for building an engineering research function that can effectively coordinate product development across multiple sites and divisions of Pro-Dex, Inc. and successfully integrate products into a cost-effective manufacturing strategy.
The successful candidate will -
- Provide strategic direction for engineering R&D programs and serve on a senior leadership team responsible for ensuring effective and innovative product development.
- Reporting to the CEO to ensure scalable product development with the focus on cost-effective design and manufacturability.
- Establish successful engineering practices for medical device development projects that will ensure compliance with GMP principles and established FDA and international guidelines.
- Work in a strongly collaborative and collegial fashion with peers and subordinates in mechanical and electrical engineering disciplines to develop products involving the release of medical devices.
- Direct project reviews and pre-production quality assurance process, which ensures that high quality products are developed with adequate controls, without excess bureaucracy.
- Work with the senior leadership team to create a sense of urgency, align priorities and achieve overall results.
The successful candidate will have/be -
- 15-20 years of successful experience in product development and or engineering management, with demonstrated leadership skills and increasing responsibilities in the medical device industry.
- BS, mechanical engineering required - Advanced degree preferred.
- Exceptional project management expertise (bringing products to market on time and on budget), setting timelines with a high degree of urgency and accuracy.
- Record of effective leadership and management skills which demonstrate a strong team player who works well in an informal, entrepreneurial environment.
- Background and experience in medical device products; experience in developing combination medical products successfully with entry into clinical trials and/or approval is highly preferred.
- Strong background and knowledge in the areas of document control and quality engineering systems; must be able to critically assess quality control in engineering with an in-depth knowledge of Quality Management Standard for Medical Devices and Quality System Regulations for both U.S. and international filings.
- Self-confident and decisive with excellent communication skills in both oral and written formats as well as excellent listening, presentation and problem solving skills; must be able to work effectively in a team of disparate technical fields.
- Collaborates closely with Marketing and New Business Development (as appropriate) to analyze market needs and potential opportunities.
- Individual must be able to routinely make decisions which affect immediate operations and may have a company-wide effect.
This position will require 20 -30% domestic travel, including approximately 5 weekends away from home.
In addition to a competitive salary Pro-Dex offers full benefits, an alternative work schedule, and a profit based bonus program. Pro-Dex is an equal opportunity employer.
Interested candidates should submit their resume with salary history and requirements to:
Corporate Manager of Human Resources
151 E. Columbine Ave
Santa Ana, CA 92707
alternative: email@example.com or fax to 714-433-7200.
*RESUMES WITHOUT SALARY REQUIREMENTS WILL NOT BE REVIEWED*
Pro-Dex specializes in bringing speed to market in the development and manufacture of technology-based solutions that incorporate embedded motion control and miniature rotary drive systems, serving the medical, dental, semi-conductor, and scientific research markets.
For additional information see the company’s website at www.pro-dex.com