Veranex
Veranex’s mission as an Innovation CRO is to improve patient outcomes by accelerating our clients’ innovations to market. As the world’s only end-to-end professional services firm focused on MedTech, we take clients’ Vision to Velocity through our comprehensive service portfolio, with expertise in human centered design and product development, preclinical and clinical research, regulatory affairs, and market access and reimbursement consulting.
General Summary Responsible 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.
Veranex is an equal opportunity employer and prohibits discrimination of any kind. All qualified applicants will receive consideration for employment without regard for race, color, religion or belief, sex (including pregnancy, gender identity or gender expression), sexual orientation, parental or marital status, disability, age, status as a protected veteran, national, social, or ethnic origin, or any other applicable legally protected characteristics.
Seniority level Mid-Senior level
Employment type Full-time
Job function Project Management and Information Technology
Industries Research Services
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General Summary Responsible 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.
Veranex is an equal opportunity employer and prohibits discrimination of any kind. All qualified applicants will receive consideration for employment without regard for race, color, religion or belief, sex (including pregnancy, gender identity or gender expression), sexual orientation, parental or marital status, disability, age, status as a protected veteran, national, social, or ethnic origin, or any other applicable legally protected characteristics.
Seniority level Mid-Senior level
Employment type Full-time
Job function Project Management and Information Technology
Industries Research Services
#J-18808-Ljbffr