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engineering Project Manager SAN JOSE, CA REF
3 months ago
engineering Project Manager SAN JOSE, CA REF
We are seeking an experienced Project Manager to lead the successful execution and launch of engineering projects in a fast-paced environment. The position has responsibility for daily management of complex projects and requires a high degree of coordination with a cross-functional team including Engineering, Manufacturing, Biology, Quality and Facilities.
Requirements
Oversee and drive multiple engineering projects of various size and complexity from initiation through validation and production release
Responsible for developing realistic project schedules, along with resource planning, risk management and measurable metrics to meet the project goals
Communicate progress to stakeholders including the executive leadership team and provide recommendations for mitigating risks or delays
Coordinate interdependent tasks and deliverables with key stakeholders including R&D Engineering, Manufacturing & Process Engineering, Facilities, EH&S, and Quality Assurance
Lead and manage team meetings by creating agendas, presentations, minutes and action items. Document team decisions and follow up on action items and deliverables
Comply with company’s policies and guidelines regarding design control, validation activities and documentation
Qualifications
BS degree in engineering or a related technical field
7-10 years of experience with managing engineering projects and use of standard project management methodology, tools and/or software packages
The successful candidate will apply strong people and negotiation skills to plan, coordinate and execute all relevant activities in a phase- gate setting
Excellent interpersonal skills with an ability to communicate to people at all levels of the organization
Strong leadership skills, self-motivated and ability to influence others to achieve successful outcomes
The position requires a high degree of adaptability, flexibility, creative decision-making, and technical problem-solving abilities
Excellent verbal, written, presentation and interpersonal skills
Must be able to handle multiple projects with exceptional organizational and time management skills
Proven experience using Project Management tools to manage complex project timelines as well as fluency with Excel, Word, PowerPoint and Visio
Proven track record with Medical Device, FDA regulations, ISO, cGMP and QMS standards
In-depth understanding of verification & validation (IQ,OQ,PQ) as well as risk analysis (FMEA)
Preferred Qualifications
PMP certification
Experience with Visual Project Management
Experience with turnkey, capital equipment
Familiarity with sterilization process and aseptic manufacturing
Travel
Up to 10%
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