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Drug/Device Sr. Program Manager
Job Summary:
The Sr. Program Manager is responsible for the successful development and delivery of their projects or programs. They instill a vision for planning and communication and promote business ownership for the projects by all members of the project teams. The Sr. Program Manager directs the activities of complex multi-disciplinary teams and organizes interdepartmental responsibilities to ensure the completion of the product/program/projects on schedule, on scope, and within budget constraints. This role involves participating as a member of the Program Management Organization that develops and deploys solutions to improve project management effectiveness across the company.
Specifically, the Sr. Program Manager for the Drug-Device combination product program will be responsible for directing activities associated with obtaining a drug indication for a temporary implant product and overseeing development of next-generation temporary implant devices, potentially in conjunction with a pharmaceutical partner. This role is comprehensive and spans the entire product development lifecycle. The PM will work closely with Strategic Marketing, Regulatory, Clinical, R&D, and Business Development leadership to architect strategies and plans for achieving our business objectives. They will also own the execution of those plans and work closely with the project team to drive results. The PM needs to have excellent intrapersonal skills and an ability to influence executives, as well as peers and team members. They will be expected to interact with physicians and potential pharmaceutical partners.
Duties & Responsibilities:
Involved in developing, modifying, and executing company strategies that affect immediate operations and may also have company-wide affect.
Works on complex projects in which the analysis of situations or data requires an in-depth evaluation of various factors, including but not limited to scope, budget, resourcing, and timeline tradeoffs.
Regularly interacts with senior management and executives on matters concerning several functional areas.
Creates and manages project(s) timelines, resources, and budget beginning with project initiation through implementation.
Organizes and manages the project team resources, develops team member capabilities, and establishes accountability for effective implementation.
Facilitates decision making.
Creates alignment amongst the team members and internal/external customers; mediates project issues, and resolves conflict.
Motivates, educates and collaborates with project teams to ensure their needs and the project needs are met
Identifies, communicates, and mitigates project risks.
Interfaces with customers and physicians on project needs, attributes, and performance, as appropriate.
Manages project/program communication up, down, and sideways of plans, status, and issues. Escalates issues as appropriate.
Prepares for and conducts appropriate reviews of project status and risks.
Provides continuous feedback for the improvements of product development, operations, and business processes.
Qualifications:
Knowledge of Medical Device Design Control, Regulatory strategies for FDA 510k, CE Mark, QSR 21 CFR Part 820 Medical Devices
Knowledge of project management and office productivity tools and systems (Word, Excel, Powerpoint, MS Project, Outlook, etc.)
BS or BA degree in engineering/science or a related field, advanced degree preferred
5 - 8+ years of project management experience preferably for medical device product development
10+ years of experience in the medical device industry?
Desired Qualifications:
Demonstrated aptitude for managing multiple medical device product development teams.
Ability to plan and manage internal, external, and cross-departmental resources to ensure all program obligations are fulfilled.
Ability to execute strategic direction and participate in developing portfolio strategy.
Ability to work as an internal consultant with multiple engineering and business stakeholders to develop detailed functional specifications and business requirements.
Ability to develop and pilot solutions, plan for contingencies, product deployment and business readiness.
Excellent interpersonal, management, and leadership skills with demonstrated ability to forge good interdisciplinary relationships and influence others.
Excellent communication skills, both written and oral.
Ability to form good relationships with a variety of personalities, influence others, change the thinking of or gain the acceptance of others in sensitive situations.
A broad understanding of new product development and commercial introduction including Stage-Gate based product development and lifecycle management with deep expertise in one or more areas preferred.
Complete understanding of the product development process and the interactions within Sales and Marketing, Material Planning, Quality, Regulatory, Clinical, R&D Engineering and Manufacturing/Operations.
Familiar with design and test document requirements and procedures, new product and process validations, test specifications, BOM and engineering change orders and their associated quality implications.
Categories: Product Management Sales general Scientist
Industry: Mechanical Devices, Mechanism, Component
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