Intersect ENT Inc. Manager, R&D in Menlo Park, California
PURPOSEOF JOB :This position is responsible for themanagement of Intersect ENT R&D.From a management perspective, you will work with the team to providestrategic and tactical direction for the concept and design development ofinnovative medical devices.You willhelp coordinate staffing, develop scheduling and budgetary requirements for theR&D Team.From a technicalperspective, this position isresponsiblefor the concept and design development of innovative medical devices.You will use your mechanical engineering andproduct development experience to design devices, device components and devicesubsystems in support of the company’s strategic plan.You will play a significant role in newproduct development, “next generation” planning and development and workclosely with physicians and the marketing group to analyze, define, and meetcustomer needs. You will both manage and perform mechanical design functionsand use your medical materials technology to develop complex designs for novelproducts.
MAJOR DUTIES ANDRESPONSIBILITIES :
- Provide tactical and strategic direction for allR&D programs and policies to assure a steady stream of new productdevelopments/enhancements.
- Direct the activities of multiple projects,pilot production, and engineering services, and motivate to successfulattainment of departmental and business objectives.
- Direct project reviews and pre-productionquality assurance process which ensures high quality products are developedwith adequate controls and without excess bureaucracy.
- Provide clear technical goals that stretch theorganization to deliver innovative products on time while minimizingdevelopment effort.
- Apply Mechanical engineering knowledge to thedesign and development of new products as well as product changes andenhancements.
- Include human factors and ergonomic considerations,part and process quality, process yield, process robustness, process throughputand process simplicity in product and process design.
- Interact with physician customers to understand theneeds of products/projects.Ensure thevoice of the customer is considered in the design and development of newproducts and components.
- Solve mechanical engineering problems at thecomponent through system level Evaluate mechanical fit of plastic parts andcomponents, conduct tolerance and stack up analysis, and verify function fromcomponent to system level.
- Solve design and development issues and implementcreative, pragmatic and efficient solutions
- Maintain accurate documentation of concepts,designs, drawings, and processes.
- Generate written protocols and reports that meetcompany and regulatory agency requirements.
- Conduct testing utilizing existing testprotocols or develop new ones as needed.
- Oversee outside vendors and consultants asrequired.
- Work with other Engineering, Manufacturing,Quality, Clinical affairs, Regulatory, and Marketing staff to coordinate pilotproduction of new products.
- Support company goals and objectives, policiesand procedures, Good Manufacturing Practices, and FDA regulations.
- Actively manage the development and documentationof new product and process IP.
Maintain current knowledge of competitivetechnologies in addition to medical, technical, and biomedical developmentsrelated to company products. EDUCATION REQUIREMENTS :BSME, BSE Materials Engineering, BSE BiomedicalEngineering or equivalent. OTHERQUALIFICATIONS :Familiarity with combination (drug/device)products desired.Experience withapplication of coatings using spray technology desired.Dilation (Balloon)/catheter manufacturing,packaging and coating experience highly desired.Experience working at a start-up or in a smallcompany environment desired. EXPERIENCE REQUIREMENTS : Minimumof 10-years of experience in the medical device industry.Experience working at a Medical DeviceStart-up Company (fast-moving atmosphere) required. PHYSICAL ACTIVITIES AND REQUIREMENTS, VISUAL ACUITY,AND WORKING CONDITIONS:
Physical Activity - Repetitive motions: Making substantial movements (motions) of the wrists, hands, and/or fingers. Fingering: Picking, pinching, typing or otherwise working, primarily with fingers rather than with whole hand or arm as in handling. Talking: Expressing or exchanging ideas by means of the spoken word.
Physical Requirements - Sedentary work: Exertingup to 10 pounds of force occasionally and/or a negligible amount of forcefrequently or constantly to lift, carry, push, pull or otherwise move objects,including the human body. Sedentary work involves sitting most of the time.Jobs are sedentary if walking and standing are required only occasionally andall other sedentary criteria are met.
- Visual Acuity - The worker is required to haveclose visual acuity to perform an activity such as: preparing and analyzingdata and figures; transcribing; viewing a computer terminal; extensive reading;visual inspection involving small defects, small parts, and/or operation ofmachines (including inspection); using measurement devices; and/or assembly orfabrication of parts at distances close to the eyes.
- Working Conditions - The worker is not substantiallyexposed to adverse environmental conditions (as in typical office oradministrative work).