Veranex, Inc.
Sr Product Development Program Manager
Veranex, Inc., Providence, Rhode Island, us, 02912
About This Role:We have an exciting opportunity to join our team as a Sr. Product Development Program Manager! This individual will be responsible for managing and executing product development program direction in accordance with the client and development team goals, plus managing a variety of programs and leading various disciplines in executing required deliverables.
What You Will Do:Develops and maintains technical Execution Strategy, while ensuring that the strategy has been submitted to and reviewed by senior management.Submits weekly product development project status/dashboards to management and/or client.Identifies and advocates for appropriate interdisciplinary resource loadings per the program Execution Strategy (i.e. technical, budgetary, and schedule needs).Maintains program oversight over all disciplines. Ensures individual discipline leaders are aware of client overall objectives, contracted deliverables, and their specific responsibilities as discipline leadership. Escalates issues as appropriate to higher level management.Develops appropriate presentations of activities during each phase of the program.Conducts post-mortem with team members and senior management on each phase during the project.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 Execution Strategy and appropriateness of the budget and timeline to successfully achieve contracted deliverables.Reviews and approves invoicing and billable hour reports to ensure complete within established timeframe.Provides leadership, training, guidance, and support to program execution staff.Qualifications:
Required skills:Bachelor’s degree in a product development related discipline plus 7-10 years of relevant work experience and experience in the 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.Strong written and oral communication 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 under tight deadlines.Ability to work in cross-functional team.Preferred:Familiarity in the design of complex medical capital equipment and disposable devices.Working knowledge of following standards that are integral to formulation and execution of medical device development strategies:
o FDA QSR:
21 CFR 820 Medical Device Quality System Regulation; Most Importantly:o Section 820.30 Design Controlso Section 820.75 Process Validationo Section 820.250 Statistical Techniqueso ISO 13485 Medical Device Quality System Managemento ISO 14971 Medical Device Application of Risk Managemento ISO 10993 Biological Evaluation of Medical Deviceso ISO 11607 Packaging for Terminal Sterilized Medical Deviceso IEC 60601 Medical Equipment Basic Safety & Essential Performanceo IEC 62304 Medical Device Software Life Cycle
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What You Will Do:Develops and maintains technical Execution Strategy, while ensuring that the strategy has been submitted to and reviewed by senior management.Submits weekly product development project status/dashboards to management and/or client.Identifies and advocates for appropriate interdisciplinary resource loadings per the program Execution Strategy (i.e. technical, budgetary, and schedule needs).Maintains program oversight over all disciplines. Ensures individual discipline leaders are aware of client overall objectives, contracted deliverables, and their specific responsibilities as discipline leadership. Escalates issues as appropriate to higher level management.Develops appropriate presentations of activities during each phase of the program.Conducts post-mortem with team members and senior management on each phase during the project.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 Execution Strategy and appropriateness of the budget and timeline to successfully achieve contracted deliverables.Reviews and approves invoicing and billable hour reports to ensure complete within established timeframe.Provides leadership, training, guidance, and support to program execution staff.Qualifications:
Required skills:Bachelor’s degree in a product development related discipline plus 7-10 years of relevant work experience and experience in the 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.Strong written and oral communication 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 under tight deadlines.Ability to work in cross-functional team.Preferred:Familiarity in the design of complex medical capital equipment and disposable devices.Working knowledge of following standards that are integral to formulation and execution of medical device development strategies:
o FDA QSR:
21 CFR 820 Medical Device Quality System Regulation; Most Importantly:o Section 820.30 Design Controlso Section 820.75 Process Validationo Section 820.250 Statistical Techniqueso ISO 13485 Medical Device Quality System Managemento ISO 14971 Medical Device Application of Risk Managemento ISO 10993 Biological Evaluation of Medical Deviceso ISO 11607 Packaging for Terminal Sterilized Medical Deviceso IEC 60601 Medical Equipment Basic Safety & Essential Performanceo IEC 62304 Medical Device Software Life Cycle
#J-18808-Ljbffr