Project Manager, OCT Systems

Requisition Number: 12-584 Job Title: Project Manager, OCT Systems Area of Interest: Research & Development Shift: 1st Position Type: Full Time - Regular Percentage of Travel Required: Up to 10% City: Billerica State/Province: Massachusetts Country: U.S. Job Summary: Volcano Corporation is dedicated to developing breakthrough technologies that save people's lives and enhance their current quality of life! At Volcano you will find a pioneering and innovative spirit with a wide range of opportunities. Without the exceptional professionals at Volcano Corporation, we simply could not fulfill our mission to improve the lives of patients worldwide. The OCT Systems Project Manager will coordinate one or more related development projects in the high resolution cardiovascular imaging space by facilitating design control and project management processes with the Core Team. This person is also expected to manage and facilitate scheduling of specific program meetings, assist with the planning, logistics, and program budgets, and maintain the project files including Design History files. DUTIES AND RESPONSIBILITIES: Provides project management support to Core Team Leader and multi-functional core team on medium- to large-sized system programs from Concept through Commercialization. Tracks progress and provides status updates. Identifies and helps to resolve conflicts and priorities to ensure the program is completed on time and within budget constraints. Manage Microsoft Project master schedule Maintain project document tracking spreadsheet with core team members Assist core team members with functional area Microsoft Project schedules, task estimation and WBS spreadsheets Reconcile budgets and monthly spending reports, identify discrepancies and support Core Team Leader with re-planning as needed Maintain DHF binders under supervision of Core Team Leader Facilitate Core Team meetings and Design Reviews, take minutes and follow up on action items with assigned owners to ensure successful completion of design control processes such as design and development planning, FMEAs, requirements development and management, design reviews, verification, validation, and post market monitoring Supports PDP initiatives and projects to establish metrics, continuously improve cycle time, efficiencies, and compliance in medical device product development such as but not limited to: Assisting core team members with the PDP Tracking and analysis of key product development and R&D metrics Leaning out the design control process and documentation Sharing project management tools, techniques and best practices Coordinate program with PMO processes and systems via Business Unit PMO representative As necessary, performs other duties as required Qualifications: MINIMUM QUALIFICATIONS, KNOWLEDGE, SKILLS AND ABILITIES: Bachelor's Degree, strong preference for a Science or Engineering field (especially electronics, computer, biomedical or software engineering) Basic PM certification a plus; PMP certification desired but not mandatory Requires 1-3 years working in an FDA/ISO 13485 regulated business 3+ years contributing to or leading the development and commercialization of a system product (intravascular medical devices preferred) comprised of two or more components such as disposable, software, hardware, electrical, and/or mechanical and its corresponding accessories Progressive history of development experience from individual contributor to project level with multi-disciplinary teams Knowledge of 21CFR Part 820 on Design Controls and the practical application of these regulations on engineering processes and documentation Knowledge and understanding of ISO standards on Medical Devices and Risk Management Experience working in or managing projects from inception to post-market sustaining using a phase-gate methodology for product development or software development lifecycles Industry experience using and applying documentation management, PLM, configuration management and change control systems Understanding of engineering principles, theories and concepts Previous technical lead/contributor experience a plus Proficient in the use of Project Management Tools for planning, scheduling, task estimation Advanced Microsoft Office skills in the following applications: Visio: Timelines, flowcharts, block diagrams, organization charts Project: Resource loading, tracking Excel: Forms, Formulas, Functions, Pivot Tables, & Graphs PowerPoint: Graphics & Animation Ability to motivate and inspire stakeholders at multiple levels; has a can-do and WIN-WIN attitude and able to instill this in others. Ability to communicate effectively both orally and in writing and to establish and maintain cooperative working relationships with persons contacted in the course of performing assigned duties including Company management and outside business associates Ability to represent the Company at professional and business functions in a competent manner Ability to maintain confidentiality Ability to organize and prioritize workflow and to meet established timeframes Ability to work under pressure Ability to assess a problem quickly and determine to what level it should be elevated LICENSES AND CERTIFICATIONS: Certificate in Project Management preferred Six Sigma certification a plus SUPERVISORY RESPONSIBILITY:  Experience working in matrixed cross-functional project teams and building collaboration among core team members TRAVEL REQUIREMENTS:  May be required to travel to other Volcano sites, customers, and vendor locations PHYSICAL DEMANDS: Ability to hear and speak to employees and outside business associates on the phone and in person Ability to see the letters and numbers on a personal computer screen and on memos, reports and other documents (near vision) NOTE: The above statements are intended to describe the general nature and level of work being performed by incumbents.  They are not intended to be an exhaustive list of all responsibilities, duties and skills required by all incumbents.  Incumbents may perform other duties as assigned.  Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.  Management retains the right to add to or change the duties of the position at any time.. Volcano is an Equal Opportunity Employer. It is the policy of Volcano Corporation, to base all employment decisions on the principles of equal employment opportunity and to take affirmative action in the employment of women, minorities, individuals with disabilities, and veterans. Apply Now