PURPOSE OF JOB: Use multidisciplinary engineering knowledge to design and develop innovative medical devices or components/subsystems in support of company’s strategic plan. Work directly with key surgeon advisers to develop and evaluate product concepts. Determine development program resource requirements, timelines, and key milestones.
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. Conduct testing utilizing existing test protocols or develop new ones as needed. Generate written reports. Assign work to vendors, 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 invention and patent applications. Maintain accurate documentation of concepts, designs, drawings, and processes. Maintain current knowledge of procedure technologies in addition to medical, technical, and biomedical developments related to company products. 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. Develop and maintain QMS systems. Provide multidisciplinary engineering support 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 production of new products. Support company goals and objectives, follow policies and procedures, adhere to Good Manufacturing Practices, and meet FDA regulations.
QUALIFICATIONS: Ability to coordinate and lead development programs according to company Design Control SOP and in compliance with company quality system. Working knowledge and demonstrated ability with CAD software, Solidworks preferred, including hardware and software performance requirements and configurations. Experience with data analysis and statistical methods applied to product V&V. Working knowledge of engineering terminology and concepts and related software applications. Demonstrated computer proficiency in Word, Excel, PowerPoint; Web savvy. Ability to travel, domestic and international as required.