General SummaryResponsible for managing and executing product development program direction in accordance with the client and development team goals. Manages a variety of programs and leads various disciplines in executing the required deliverables. Primary Responsibilities• Develops and maintains schedule, ensures schedule has been reviewed and submitted to management. Submits weekly product development project status to management and/or client.• Advocates and maintains appropriate interdisciplinary resource loadings needed to maintain product development project deliverables, including budget and schedule. Ensures team members are accurately entering hours into the accounting system on a weekly basis.• Maintains program oversight over all disciplines. Ensures individual discipline leaders are aware of client overall objectives and the responsibilities to their responsibilities to the specific programs. Escalates issues as appropriate to higher level management.• Develops appropriate presentations of activities during each phase of the program. Ensures each presentation is reviewed by senior management prior to submitting to client. • Conducts post-mortem with team members and senior management on each phase during the project. Level-Specific Responsibilities Manages the maintenance of overall client program. Coordinates all aspects of program activities. Monitors internal resources to ensure all products are developed within cost targets and delivered on schedule. Drafts and reviews program proposals advising on approach and appropriateness of the budget and resource estimates. Submits weekly project status dashboards to internal management and/or client. Manages invoicing and reviews/approves billable hour descriptions to ensure complete within established timeframe. Manages out of scope work approval process. Provides leadership, training, guidance, and support to program management staff. Knowledge, Skills and Abilities Knowledge of overall medical device industry Strong knowledge of the professional services industry and management of customers Strong knowledge of appropriate regulatory regulations Strong understanding of design and document controls, design verification and validation, hazard analysis techniques, regulatory approval methods Understanding of mechanical engineering development processes Understanding of electronics and software development Familiarity in the design of complex medical capital equipment and disposable devices Sound program management skills Strong written and oral communication skills Strong interpersonal skills Excellent attention to detail Ability to establish and maintain effective working relationships with project team and client Ability to multi-task and perform a wide range of activities Ability to work under a timeline Good ability to work in cross-functional teams Complexity A seasoned professional with full understanding of medical device product development. Resolves a wide range of issues in creative ways. Problem Solving Works on problems of diverse scope where analysis of data requires evaluation of identifiable factors. Exercises judgment in selecting methods and techniques for obtaining solutions. Networks with senior internal and external personnel in area of expertise. Supervision Works independently; receives minimal guidance on day-to-day work and new projects or assignments. Typical Minimum Education Requirement Bachelor's degree in a product development related discipline Typical Minimum Experience Requirement 7-10 years of relevant work experience Physical Requirements Work is typically performed in an office environment, using basic muscular movements, involving only the handling of light materials, tools, or equipment in easy work positions, and with no special speed requirements or long stretches of exertion. Equivalent combination of education, training, and relevant experience may be considered in place of the education and experience stated above. This job description is intended to present the general content and requirements for the performance of this job. The description is not to be construed as an exhaustive statement of duties, responsibilities, or requirements.
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Job Type
Full-time
Career Level
Mid Level
Industry
Professional, Scientific, and Technical Services
Number of Employees
1,001-5,000 employees