Product or Program Manager (medical device engineering)

Use multidisciplinary engineering knowledge and project engineering skills to design and develop innovative medical devices or components/subsystems in support of company’s strategic plan.

MAJOR DUTIES AND RESPONSIBILITIES: Apply broad engineering knowledge to the design and development of new products as well as product changes and enhancements which are consistent with a zero defect level as well as low product cost. Solve multidisciplinary engineering problems at the component through system level. Conduct testing utilizing existing test protocols or develop new ones as needed. Generate written reports. Assign work to technicians and temporary workers as needed. Complete projects (including product enhancements) in a manner consistent with corporate objectives. Contribute to the intellectual property position of the company via input into invention and patent applications. Maintain accurate documentation of concepts, designs, drawings, and processes. Provide multidisciplinary engineering and technical support of products introduced into both the domestic and international markets as well as physician in-service programs. Oversee outside vendors and consultants as required. Maintain QSR systems, including pre-production quality assurance procedures, pre-clinical testing programs, and post production QSR compliance in coordination with the Document Control, Clinical, and Quality Assurance functions. Provide multidisciplinary engineering support of clinical investigation, and in the resolution of product complaints and/or safety issues. Work with other engineering, manufacturing, clinical affairs, sales and marketing, and quality assurance staff to coordinate pilot production of new products. Support company goals and objectives, policies and procedures, QSR, and FDA regulations.
REQUIREMENTS
EDUCATION / EXPERIENCE REQUIREMENTS: BS and 8 or more years relevant experience or MS and 6 years relevant experience.

OTHER QUALIFICATIONS:
Working knowledge of engineering terminology and concepts. Ability to perform word processing and create basic spreadsheets.