Acclarent, Inc., a member of Johnson & Johnson's Family of Companies, is recruiting for a Program Manager, located in Menlo Park, CA.
Acclarent, Inc. is a medical device company in Menlo Park, CA that was established in June of 2004. The company is dedicated to the development of innovative devices providing new technologies to further meet the needs of ENT patients.
Acclarent's initial focus is on achieving the goals of sinus surgery with novel, endoscopic, catheter-based tools -
™ devices. Through the
™ technology and our Relieva® product portfolio we offer ENT patients another option to conventional endoscopic surgical technologies. FDA clearances for these devices were completed in 2005 and the products were commercially launched in the US that same year.
Through our core technologies and commitment to innovation, Acclarent will continue to advance novel devices in all areas of ENT.
The Program Manager is responsible for the successful development and delivery of projects or programs. He or she instills a vision for planning and communication and promotes business ownership for the projects by all members of the project teams. The Program Manager directs the activities of complex multi-disciplinary teams and organizes interdepartmental responsibilities to ensure the completion of the programs/ projects/products 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.
DUTIES & RESPONSIBILITIES
Leads project teams to deliver expected deliverables on time and on budget. Informs stakeholders and gains agreement to any changes to scope, schedule, or budget.
Works on complex cross-functional 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. 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. Motivates, educates and collaborates with project teams to ensure their needs and the project needs are met
Facilitates decision making and drives teams to decisions that are timely and data-based. Informs and aligns the team and upper management to key decisions. Resolves conflict within the team and with stakeholders.
Identifies, communicates, and mitigates project risks. Leads the project team to retire risk early in the project.
Manages project/program communication up, down, and sideways of plans, status, and issues. Escalates issues as appropriate. Regularly interacts with senior management. Interfaces with customers and physicians on project needs, attributes, and performance, as appropriate.
Prepares for and conducts appropriate reviews of project status and risks including formal design reviews and informal management updates.
Provides specific suggested improvements and implements changes to product development, operations, and business processes. Establishes or modifies process to support Acclarent's growth trajectory.
QUALIFICATIONS (Required Education and Experience):
Bachelor degree in engineering/science or a related field and 4 - 6 years of project oversight or MS degree and 2- 4 years of project oversight is required.
5 -7 years of experience in the medical device industry or technology industry is required.
Knowledge of Medical Device Design Control (QSR 21 CFR Part 820 Medical Devices) and regulatory strategies for FDA 510k and CE Mark are required. Knowledge of project management and office productivity tools, which may include Word, Excel, PowerPoint, MS Project, and Outlook are required.
You must have Track record of successful project completion and excellent written and oral communication skills.
Desired Qualifications - if applicable:
Demonstrated aptitude for managing multiple medical device project development teams.
Ability to plan and manage internal, external, and cross-departmental resources to ensure all program obligations are met. Ability to develop and pilot solutions, plan for contingencies, product deployment and business readiness.
Ability to think creatively within the constraints of the design control system and established processes to reduce delays, retire risk, and increase probability of project success.
Excellent interpersonal, management, and leadership skills with demonstrated ability to forge good interdisciplinary relationships and influence others with a variety of personalities.
A broad understanding of new product development and commercial introduction including Stage-Gate based product development and lifecycle management.
A broad understanding of the product development process and the interactions within Sales and Marketing, Material Planning, Quality, Regulatory, Clinical, R&D Engineering and Manufacturing/Operations.
Familiarity 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.
Experience working with outside suppliers who are both developing and manufacturing final products.
North America-United States-California-Menlo Park
Acclarent, Inc. (6206)
Johnson & Johnson Family of Companies - 2 years ago