Randstad Program Manager in San Diego, California
San Diego, CA
Wednesday, September 28, 2016
The Program Manager (PM) will be responsible for leading cross functional teams managing the development and implementation of new products.
In compliance with the company s Product Development and Commercialization processes, the Program Manager will lead projects through the phase gate approval process. Because products are for In Vitro Diagnostics (IVD), the Program Manager will contribute to the definition of project strategy to deliver products that meet applicable regulations of the FDA, ISO 13485, and other international standards products.
Tasks and responsibilities
Provides program management expertise for medium to large scale programs.
Leads a multi-functional core team from Concept through Launch; through proper execution of Design Controls that includes efficient transfer of product from Global R&D to manufacturing and global marketing through post release to achieve project closure at Gate 5;
Works closely with various disciplines within R&D and Marketing, Clinical, Quality, Regulatory, Manufacturing, and establishes program plans and objectives;
Develops cost analysis, creates and manages the integration of project schedules, program budget;
With the enterprise organizations, resolves resource allocation issues, conflicts, and priorities to ensure the program is staffed appropriately, completed on time, and within budget constraints.
Tracks progress and communicates proactively the impact of changes (e.g. scope, cross functional resources, timelines, costs, etc.) to key stakeholders.
Ensure that teams are equipped and prepared per the appropriate PDG phase requirements to present at key business and design review meetings; that all appropriate stakeholders within and outside the BU are apprised of review meetings and the results thereof.
Manage the process for device integration acceptance into the corporate platform(s).
Ensures that CTQ s (Critical to Quality) and KPIV s (Key Process Input Variables) are well defined, reviewed and implemented for all projects within the program.
Ensures that Design Reviews for system readiness include all appropriate stakeholders outside of the sub-system or individual device.
Ensures that the Acceptance criteria for system level integration are completely aligned with the design and project management requirements for integration. Facilitate team process needed to meet requirements to demonstrate system level integration readiness.
Ensures the timely collaboration and coordination of design requirements, cross functional resourcing, and scheduling between projects, sites, and platform/system level organizations.
Ensure system level compliance and enforce quality practices (e.g. facilitate Design Reviews, Key Learnings, etc.).
Support the BU s strategic planning and prioritization process by coordinating and providing specific project information (e.g. project descriptions, effort assessment, labor and cost requirements, etc.) within the program.
Support the budget planning process for both existing and candidate projects within the program. Coordinates appropriate meetings and collaboration needed to support PMO s resource allocation and planning process.
Presents and provides data to support the publication of the BU s monthly project dashboards, Program Reviews, and messaging.
Leads the teams through best practices in planning such as scrum, creating work breakdowns, schedule development, and critical chain analysis.
Provide training or mentorship to the core team and other project leaders in order to elevate efficiencies and facilitate compliance to the Product Development Governance and Design Change Processes.
Works with Design Quality and ensures that all DHF s are complete and assessed for quality and completeness at each phase of product development.
Assist in establishing program and BU portfolio metrics aligned with the standards and guidance provided by corporate PMO.
Ensures the implementation of new standards on requirements and specifications development, management, and traceability on projects (e.g. Requirements Flow-down, Capabilities Flow-Up, CTQ s, etc.)
Demonstrates commitment to the development, implementation and effectiveness of Quality Management System per ISO, FDA, and other regulatory agencies.
Perform other duties & projects as assigned.
Requires a bachelor s degree in Engineering or equivalent training
Requires PMP certification or equivalent
Advanced degree or equivalent is a plus
Scrum certification is a plus
Requires 5-10 years Program Management experience in the IVD or medical device industry
Requires experience managing multiple product development products from inception to global commercialization using a phase-gate methodology
Experience in the practical implementation of regulatory requirements for medical device development such as FDA s Design Controls, ISO s Risk Management and Medical Device standards, ISO Software Development standards, CLIA
Requires experience in leading cross functional core teams and extended teams