US_West | Project Manager_L

Position: US_West | Project Manager_L2
Description:

Need R2D2 # ,
Possible 3 Month CTH | No Fees | Do Not Re-Post | Confidential
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IMPORTANT INFORMATION:

Role:
Project Manager
Work Location San Francisco, CA
Rate: $85.00/hr AI

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JOB DESCRIPTION:

"self-starter responsible for managing product improvement and infrastructure projects associated with the company's products and services. Coordinates departmental or cross-functional teams, focused on delivering upgrades to existing products and/or infrastructure projects. Monitors the project from project planning through launch, including planning and directing schedules and monitoring budget/spending. Organizes cross-functional activities, ensuring completion of the project (i.e. product on schedule and within budget constraints).

Primary objective is to deliver projects on schedule, within project budget, meeting all technical requirements, and within product Cost Of Goods target.

ESSENTIAL DUTIES AND RESPONSIBILITIES:

+ Develops and manages project objectives, plans, schedules, and budget.
+ Maintains project schedule by monitoring project progress, coordinating activities, resolving issues, and proactively managing risks/ opportunities.
+ Manages cross-functional project team to achieve project objectives.
+ Manages the suppliers, vendors, and subcontractors on each project.
+ Proposes and implements design solutions in order to meet product specifications.
+ Responsible for product specification, verification and validation.
+ Conducts project proposals and feasibility studies.
+ Assists in the development and maintenance of product/ project documentation required by Engineering SOPs and national/international quality standards and regulations.
+ Stays up-to-date and follow all Quality System procedures related to this job, which can affect the quality of products or services provided to our customers.
+ Delivers medical device design documentation compliant with FDA design controls and good documentation practices
+ Creates and maintains medical device Design History Files and Device Master Records
+ Identifies potential medical device hazards and maintains Risk Management files
+ Conducts medical device safety testing and maintains product compliance with applicable UL, ISO, and IEC 60601 standards as well as international regulatory requirements
+ Investigates and resolves product related Corrective and Preventative Actions using appropriate problem solving techniques (DMAIC, FMEA, Ishikawa, Fault Tree, etc.)

Education and/or Experience Requirements:
+ Bachelor's Degree (B.S.) in Mechanical, Electrical or Systems Engineering from a four-year college or university.
+ Previous project management experience in medical device (Class II and Class Ill devices).
+ Minimum 7-10 years related experience required.
+ Minimum 3 years experience as a Lead Project Engineer responsibility developing complex systems within program management and systems engineering environment.
+ Minimum 3 years experience as a Systems Engineer responsibility involving requirements development and management.

Additional

Skills and Abilities:

+ Familiarity with medical device design control regulations (21 CFR 820.30)
+ Strong Project Management skills, Agile/Scrum experience a plus
+

Experience with requirements management tools such as DOORS
+ Familiar with Risk and Opportunity Management
+ Excellent computer skills, including Microsoft Project, Visio, and Office
+

Experience with PLM and Product Data Management (PDM) systems
+ Familiarity with ISO and FDA regulations and standards a plus
+ Competency in FDA Quality System Regulations, Current Good Manufacturing Practices, and ISO 13485 Quality Management Systems for Medical Devices
+ Competency in medical device risk management (ISO 14971)
+ Competency in human factors engineering and usability engineering for medical devices (IEC
60606-1-6, IEC 62366, ANSI/AAMI HE7S)
+ Competency in medical device safety standards (IEC 60601)
+ Competency in medical device software life cycle process (IEC 62304)
"

ERM - Joaquin Zamora | Capgemini |North America
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