MANAGER, R&D (#14-8017) AccessClosure
THIS JOB HAS EXPIRED FLSA: Exempt
Posting Date: 2/6/2014
Location: Santa Clara
SUMMARY: Plans, directs, and coordinates activities of designated project to ensure that goals or objectives of projects are accomplished within prescribed time frame and funding parameters of the R&D group and transfer to manufacturing by performing the following duties personally or through subordinate project staff.
ESSENTIAL DUTIES AND RESPONSIBILITIES include the following. Other duties may be assigned on an individual basis:
Interface with senior management to review project goals and priorities.
Plan and formulate engineering project plans and organize project staff according to project requirements.
Identify and assign project personnel to specific phases or aspects of project (e.g. product design and process development, pre-clinical studies, design and process characterization and qualification, finalization of specifications, strategic project/ technical plans, etc).
Recruit, hire, develop, supervise, and train Research and Development personnel, including performance reviews, in accordance with departmental and corporate practices
Review product design for compliance with engineering principles, company standards, and customer requirements, and related specifications.
Coordinate activities concerned with technical developments, scheduling, and resolving engineering design and test problems.
Direct integration of technical activities and support activities related to project (i.e. marketing, regulatory, quality, clinical, manufacturing).
Evaluate and approves design changes, specifications, and drawing releases.
Conduct budgeting, planning, and resource evaluation.
Initiate activities with contract vendors (mfg, sterilization, testing, shipping)
Attend professional meetings (e.g. Professional conferences, AHA, TCT, Symposia) to build network of contacts, advance technological knowledge and ensure professional expertise is maintained.
Project Planning /Management
Develop new product and/or enhance existing design based on customer input and product requirements.
Regularly communicate timelines and risk factors to senior management
Take appropriate risks to accelerate timelines with a clear assessment of possible downsides.
Identify critical path and clearly communicate the impact to the project team.
Work with cross-functional teams to understand product requirements.
Partner with Regulatory Affairs to formulate robust regulatory strategies and adjust as necessary.
Plan projects with a clear understanding of the trade-offs between scope, timeline, and resources.
Initiate and update requirements for the Project.
Lead and contribute to brain storming discussions.
Conduct design reviews as necessary from development through commercialization of the product according to AccessClosure design control procedure.
Develop and maintain project plan.
Oversee of generation and maintenance of product design history file.
Initiate and participate in animal studies and prepare protocols and reports.
Prepare test protocols, oversee testing and result documentation, and write the final report.
Generate design and process specifications.
Travel to professional meetings, customer visits and clinical studies.
Bachelor of Science degree in engineering discipline or equivalent, and a minimum of 8 years? related work experience (including minimum 3 years? experience in medical device product development.)
Excellent leadership and management skills
Strong interpersonal skills, effective interaction with R & D and other cross-functional management to drive projects forward
Clear and effective communication Skills
Minimum 7 years engineering experience in medical device field
Minimum 2 years of functional engineering management.
Work includes potential exposure to human bloodborne pathogens or other potentially infectious materials.
Work includes potential exposure to radiation sources such as fluoroscope in a catheter laboratory setting.
Work includes potential exposure to chemicals.
May have supervisory responsibilities, including management of the performance and development of direct report staff; overall direction, coordination, and evaluation of work activities
||Santa Clara, CA |
THIS JOB HAS EXPIRED