Senior R&D Engineer - Project Manager
1555 Adams Drive Menlo Park, CA 94025
Menlo Park, CA
PURPOSE OF JOB: The Senior R&D Engineer-Project Manager is responsible for cross functional project team coordination from product definition through product commercialization. Using engineering and product development knowledge, manages the design and development of innovative medical devices in support of the company’ s strategic plan. Responsibilities include, understanding of process development, design control, clinical and regulatory affairs. Will lead project teams, managing team action items and creating and driving project schedules.
MAJOR DUTIES AND RESPONSIBILITIES:
- 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
- Solve design and development issues and implement creative, pragmatic and efficient solutions
- Provide engineering and technical support of products introduced into both the domestic and international markets as well as physician in-service programs.
- Apply engineering knowledge to troubleshoot and solve product testing issues as needed.
- Solve engineering problems at the component through system level.
- Oversee outside vendors and consultants as required.
- Maintain accurate documentation of concepts, designs, drawings, and processes.
- 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.
- Determine the objectives and measures upon which the project will be evaluated at its completion.
- Complete projects (including product enhancements) in a manner consistent with corporate objectives.
- Ensure projects are run in compliance with company, FDA, and ISO procedures.
- Create and monitor project budgets as needed.
- Determine resources required to complete projects and communicate results to appropriate management.
- Proactively identify resource constraints and recommend solutions to appropriate management.
- 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.
- Assign work to technicians and temporary workers as needed.
- 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.
EXPERIENCE REQUIREMENTS: Five or more years of experience in the medical device industry.
- Pro Chain or MS Project software experience
- 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 ACTIVITIES AND 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.
- The worker is not substantially exposed to adverse environmental conditions.