OBJECTIVE OF POSITION :
This position is responsible for the management of Intersect ENT R&D. From a management perspective, you will work with the team to provide strategic and tactical direction for the concept and design development of innovative medical devices. You will help coordinate staffing, develop scheduling and budgetary requirements for the R&D Team. From a technical perspective, this position is responsible for the concept and design development of innovative medical devices. You will use your mechanicalengineering and product development experience to design devices, device components and device subsystems in support of the company’s strategic plan. You will play a significant role in new product development, “next generation” planning and development and work closelywith physicians and the marketing group to analyze, define, and meet customer needs. You will both manage and perform mechanical design functions and use your medical device development experience to develop complex designs for novel products.
MAJOR DUTIES AND RESPONSIBILITIES :
- Provide tactical and strategic direction for all R&D programs and policies to assure a steady stream of new product developments/enhancements.
- Direct the activities of multiple projects, pilotproduction, and engineering services, and motivate to successful attainment of departmental and business objectives.
- Direct project reviews and pre-production quality assurance process which ensures high-quality products are developed with adequate controls and without excess bureaucracy.
- Provide clear technical goals that stretch the organization to deliver innovative products on time while minimizing development effort.
- Apply Mechanical engineering knowledge to the design and development of new products as well as product changes and enhancements.
- Include human factors and ergonomic considerations, part and process quality, process yield, process robustness, process throughput and process simplicity in product and process design.
- Interact with physician customers to understand the needs of products/projects. Ensure the voice of the customer is considered in the design and development of new products and components.
- Solve mechanicalengineering problems at the component through system level Evaluate mechanical fit of plastic parts and components, conduct tolerance and stack up analysis, and verify function from component to system level.
- Solve design and development issues and implement creative, pragmatic and efficient solutions
- Maintain accurate documentation of concepts, designs, drawings, and processes.
- Generate written protocols and reports that meet company and regulatory agency requirements.
- Conduct testing utilizing existing test protocols or develop new ones as needed.
- Oversee outside vendors and consultants as required.
- Work withotherEngineering, Manufacturing, Quality, Clinical Affairs, Regulatory, and Marketing staff to coordinate pilotproduction of new products.
- Support company goals and objectives, policies and procedures, Good Manufacturing Practices, and FDA regulations.
- Actively manage the development and documentation of new product and process IP.
- Maintain current knowledge of competitive technologies in addition to medical, technical, and biomedical developments related to company products.
EDUCATION REQUIREMENTS : BSME, BSE Materials Engineering, BSE Biomedical Engineering or equivalent.
OTHER QUALIFICATIONS and MUST HAVES : Familiarity with combination (drug/device) products desired. Experiencewith application of coatings using spray technologydesired. Dilation (Balloon)/catheter manufacturing, packaging, and coating experience highly desired. Experience working at a start-up or in a small company environment desired.
EXPERIENCE REQUIREMENTS : Minimum of 10-years of experience in the medical device industry. Minimum of four years of management experience. Experience working at a Medical Device Start-up Company (fast-moving atmosphere) required.
Job Type: Full-time
- Management: 4years
- working in the Medical Device Industry: 10 years
- working at a Medical Device Start-up Company: 1year
- managing/performing mechanical design functions: 1year
- familiarity with combination (drug/device) products: 1year