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Reference # : 17-93112 Title : Project Manager
Location : South San Francisco, CA
Position Type : Contract
Experience Level : Start Date : 12/15/2017  


Artech is currently seeking to add to the below position

Job Title: Project Manager I
Job ID: 7636077
Location: SSF56,500 Forbes Blvd, South San Francisco, CA 94080
Duration: 2 Years contract

The Project Manager (PM) will support 2 to 3 projects depending on the stage and complexity level of the program.  
Project assignments will include pipeline, product care, technology and/or continuous improvement initiatives.  
The PM is expected to support project activities while onsite with the flexibility to coordinate meetings and travel to enable global time zone interactions dependent on project needs.  

The Project Manager (PM) in partnership with the Device Team Leader (DTL) will facilitate translation of the device strategy into a plan for execution at the Team level.  The Project Manager will lead execution of the device development plan within the agreed-upon constraints of scope, time and cost:
1)    Facilitate effective planning with the Team to define "inspection ready” Design & Development Plans 
2)    Drive execution of Team activities to meet project and design control deliverables 
3)    Drive closure of Team actions to enable advancement to next stage through an effective Design Review process

The PM will proactively drive planning and execution of the device strategy through the effective use of PM best practices and integration of Quality System Requirements (QSR) including design controls into Team activities.  
This will involve oversight of project plan execution through the close monitoring of critical path activities and the creation of contingency plans to resolve issues and achieve deliverables.  
The project plan will effectively integrate with the Technical Development Team (TDT) plan to meet schedule and budget requirements.  
The PM is responsible for promoting a collaborative team environment and maintaining positive team dynamics to enable on time execution.   A strong emphasis on effective meeting management, transparent team communication, efficient decision-making, proactive risk management, conflict resolution and problem-solving is required.  
The Project Manager is responsible for applying best practices, driving consistency, and facilitating effective communication to enable optimum Device Team performance in a regulated environment.  
A variety of processes and tools will be used to manage the information flow & meetings (communication), team dynamics, budget, schedule, compliance and project risk management. 
With these processes the PM will enable the Team to effectively perform in meeting their deliverables. 
For continuous improvement initiatives the PM will establish goals, drive deliverables to completion and will represent PTDU-D as the primary contact.

Job Responsibilities
Project Management:
Maintains full understanding of program milestones for the Core, Lifecycle, Technical Development and associated teams and links them to the Device Team plan 
Effectively applies PM best practices and utilizes tools for planning, communication, team building, collaboration, decision-making, issue & risk management, lessons learned, knowledge management and budget tracking 
Develops & updates Design & Development Plan and establishes contingency plans as needed
Ensures transparent communication of key team information and escalates issues as appropriate
Establishes positive team dynamics through team building
Promotes collaborative environment across team members
Facilitates efficient decision-making and issue resolution
Identifies team risks and mitigation plans

Project Planning and Execution:
Proactively manages project and team to achieve deliverables and solve issues.  
Manages project scope and facilitates project changes as required 
Leads project plan development and execution 
Develops, monitors, and controls the detailed project schedule 
Drives change for improved efficiency and/or optimization
Facilitates effective decision-making and escalation of issues
Integrates project deliverables with other Teams linked to product (e.g. TDT) 
Integrates external collaborator plan(s) with Device Team project plan 

Project Issue and Risk Management: 
Anticipates and manages risks efficiently using proactively defined contingency plans as appropriate
Leads the Device Team project risk management process using the TDT Risk Management Tool 
Facilitates and lead Team issue and conflict resolution 

Collaboration and Team Building:
Assesses Team dynamics and leads team building activities to enable and sustain a high performing team environment 
Establish relationships and network with other stakeholder Teams and PMs

Develops and adapts project communication tools to drive awareness of project progress and risks across stakeholders including external collaborators (e.g. dashboard) 
Acts as Device Team Leader back-up for Team communication as required 
Liaises with other Teams to manage cross-functional activities and issues and risks

Meeting Management: 
Effectively facilitates Team meetings with meaningful desired outcomes, appropriate participants, minutes, actions and follow up 
Participates in CMO and Partner meetings and integrates relevant outcomes into project plan

Budget and Resource Planning:
Actively forecasts and monitors Device Team resource (FTE) and project variable costs (PVCs)

Knowledge Management: 
Establishes centralized Team access to all relevant project information 
Manages Team uncontrolled document repository (e.g. Project History File) 
Conducts lessons learned exercises during project execution and share outcomes to a broader audience 

Effectively navigates the Device Team through business process stage-gates 
Supports Team Leader with technical advisory and governance committee reviews at pre-defined check-in points and/or identifies appropriate check-in points

 Continuous Improvement Initiatives:
Leads business process continuous improvement initiatives through applying project lessons: business process updates, PM tool optimization & implementation, best practice sharing and driving awareness across teams.

Quality System Requirements:
Effectively applies Quality System and Roche PQS requirements for team activities and deliverables
Facilitates planning and maintains the Design and Development Plan (DDP) with Team input 
Oversees Design Review planning, execution and closure of actions and completes DHF records
Effectively utilizes e-document system to maintain Design History File in compliance with PQS requirements 
Supports internal and health authority audits as required

Education and Industry Experience
B.S. or B.A degree, preferably in Engineering, or the equivalent.
At least 5 to 10 years' experience with at least 5 years relevant industry experience, preferably a multi-site global company in the medical device, pharmaceutical or biopharmaceutical, after receiving Bachelor's degree 

Drug and/or Medical Device development & commercialization experience preferably with Combination Products 

Technical Knowledge
Project Management best practices:  communication, scheduling, budget & resource planning, team building  and risk management 
PMP certification considered an asset
Solid knowledge and understanding of 21CFR820.30 design control requirements
Software tools: Microsoft Office (Project & Excel), Google, WebEx, Visio, Planisware

Demonstrated ability to work independently to manage complex projects with multiple priorities in a fast-paced, ever-changing, team-based environment
Excellent oral and written communication skills (listening, negotiation, presentation, organizational and relationship-building) required  
Ability to effectively communicate in a highly matrixed organization and with external parties

Please apply on our company website ( with reference to job ID, or contact me at / 973.507.7539
Team Lead – Staffing
Artech Information Systems LLC
360 Mt. Kemble Avenue, Suite 2000 | Morristown, NJ 07960
Office: 973.507.7539 | Fax: 973.998.2599
Email: | Website:
About Artech Information Systems LLC
Artech is an employer-of-choice for the last 25 years to over 7,500 consultants across the globe. We recruit top-notch talent for over 70 Fortune and Government clients coast-to-coast across the U.S., India, and China. We are #1 Largest Woman-Owned IT Staffing Firm in the US and this may be your opportunity to join us! For more check:
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