Intersect ENT Inc. Product Development Manager, R&D in Menlo Park, California
PURPOSEOF JOB :Responsible for the management of IntersectENT Product Development/Program Management function.Works with Program Managers/Project Leadersto provide strategic and tactical direction for cross functional project teamcoordination from product definition through product commercialization.Works closely with physicians and themarketing group to analyze, define, andmeet customer needs.Usingproduct development knowledge, manages the design and development of innovativemedical devices in support of the company’s strategic plan.
MAJORDUTIES 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, pilot production, and engineering services, and motivate to successful attainment of departmental and business objectives.
- Insure projects are run in compliance with the Design Control Procedure or their subordinate procedures, including chairing design reviews, creating design history files, etc.
- Act as an interface and conduit across company-wide functional organizations to meet and coordinate required project time lines.
- Interface and assist team members in achieving corporate goals and other related project tasks
- Assign work to technicians and temporary workers as needed.
- Oversee outside vendors and consultants as required.
- Complete projects (including product enhancements) in a manner consistent with corporate objectives.
- Solve design and development issues and implement creative, pragmatic and efficient solutions
- Provide mechanical engineering and technical support of products introduced into both the domestic and international markets as well as physician in-service programs.
- Generate written protocols and reports that meet company and regulatory agency requirements.
- Apply engineering knowledge to troubleshoot and solve product testing issues as needed.
- Maintain accurate documentation of concepts, designs, drawings, and processes.
- Maintain current knowledge of competitive technologies in addition to medical, technical, and biomedical developments related to company products.
- Maintain GMP systems, including pre-production quality assurance procedures, pre-clinical testing programs, and post-production GMP compliance in coordination with the Document Control, Clinical, and Quality Assurance functions.
Create and monitor project budgets as needed.
Determine resources required to complete projects and communicate results to appropriate management.
- Actively manage the development and documentation of new product and process IP.
- Solve mechanical engineering problems at the component through system level.
- Determine the objectives and measures upon which the project will be evaluated at its completion.
- In coordination with the appropriate management, assign tasks to cross functional team members to ensure timely project completion.
- Ensure that the project deliverables are on-time, within budget and at the required level of quality.
- Proactively identify resource constraints and recommend solutions to appropriate management.
- Ensure projects are run in compliance with company, FDA, and ISO procedures.
EDUCATIONREQUIREMENTS :BSME, BSE Materials Engineering, BSEBiomedical Engineering or equivalent.
EXPERIENCEREQUIREMENTS :8 or more years of experience in the medicaldevice industry.
- Pro Chain or MS Project software experience
- Experience running large and complex projects
- Medical Device industry experience
- Pharmaceutical Industry experience a plus
- Ability to respond to common inquiries or complaints from team members
- ISO and FDA guidelines as they apply to Product Development
- Clear and effective verbal and written communication skills
- Well organized, detail oriented and self-motivated
- Team player who excels in a demanding environment
PHYSICAL ACTIVITIESAND REQUIREMENTS, VISUAL ACUITY, AND WORKING CONDITIONS :
- Fingering: Picking, pinching, typing or otherwise working, primarily with fingers rather than with whole hand or arm as in handling.
- Sedentary work: Exerting up to 10 pounds of force occasionally and/or a negligible amount of force frequently 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 and all other sedentary criteria are met.
- The worker is required to have close visual acuity to perform an activity such as: preparing and analyzing data and figures; transcribing; viewing a computer terminal; extensive reading; visual inspection involving small defects, small parts, and/or operation of machines (including inspection); using measurement devices; and/or assembly or fabrication of parts at distances close to the eyes.