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Project Manager
Medical Devices
Location: East Central

Responsible for managing internal and external R&D, PD&D and other related new product projects. Justify, plan, manage and implement projects associated with new product designs, medical devices, quality improvement, capacity improvement, cost reduction, redesign of existing products and regulatory compliance. Utilize current industry-acceptable techniques to provide project proposals and estimating, budget control and event tracking. Principle, when applicable, for interaction with customers to achieve both product and customer satisfaction; extensive interaction with all departments.

RESPONSIBILITIES:

Project management of new innovative products; maintaining the Company’s position as the market leader in product innovation and product quality.

Take project speculative ideas and ideas/concepts from clients, Company Commercial Development and Technology groups. Develop project proposals in accordance with the Project Management Guidelines including project justifications, plans, cost models, resource assessments and budgets from project feasibility through concept, development, validation, pilot production, transfer into scale up and full production.

Provide project management and coordination between all departments, clients and external contractors.

Ensure quality and excellence in Project Management goals and activities.

Responsible for ensuring projects are funded internally/externally and are financially viable.

Develop project budgets and monitor expenses for budget compliance.

Responsible for all Project Management documentation including those defined in the Project Management Guideline and the Product Development Procedure.

Work with all departments to analyze rationale, investment requirements, development timing, market potential, and return on investment for new product developments and improvements to existing products. Presenting this information and project updates effectively and concisely to staff at all levels.

Responsible for writing proposals and schedules for product development programs.

Delegate to project team members the responsibility and authority necessary to function effectively. Manage and apply focused guidance as needed.

Creation and maintenance of Project and Product History Files.

Maintaining compliance with the Product Development Procedure and cGMP.

Must be able to contribute to strategic and organizational strategy when necessary.

Coordinate the preparation of information for submission to patent attorney for patent applications.

Prepare and control Product History File information for FDA NDA’s, supplementary approvals, 510k’s, etc.

EDUCATION:

Bachelor’s degree in Engineering, Science or Business - Graduate degree preferable.

Recognized qualification or training in project management.

Preferably a member of the Project Management Institute and a Project Management Professional.

EXPERIENCE:

Seven-plus combined years project management/technical experience in progressive positions, preferably in the medical device industry (medium to high volume manufactured products, project value: $1 mil - $20 mil). Extensive project management experience in new product development. Proven ability to organize and lead a project team.

Proven excellence in project management

Budgetary control

Conflict resolution

SPECIFIC SKILLS:

High level of professional credibility

Excellent leadership and interpersonal skills

Excellent written and verbal communications and presentation skills

Must be highly organized, dynamic, and motivated project leader

Formal training – project management, manufacturing/engineering/scientific

High level of computer literacy in Word, Excel, Power Point, Microsoft Project, Access, Outlook, Lotus Notes

Risk management

Problem solving techniques

Data analysis

c.GMP, FDA, QSR, QA

Medical device, pharmaceutical or scientific experience

Understand technical, engineering & scientific documents & practices

Must be able to communicate effectively with staff at all levels

Understanding of manufacturing in an FDA regulated environment

Able to focus on priorities and have a high sense of urgency

Ability to work under pressure

Enthusiastic, positive & dynamic