Project Manager - San Jose
San Jose, CA
Must be a US Citizen or Green Card holder.
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.
- 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
- 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)
- PMP certification
- Experience with Visual Project Management
- Experience with turnkey, capital equipment
- Familiarity with sterilization process and aseptic manufacturing
Up to 10%
Required Knowledge, Skills, and Abilities: (Submission Summary):
1. BS Degree in engineering or a related technical field.
2. 7-10 years of experience with managing engineering projects and use of standard project management methodology, tools and/or software packages.
3. Ability to handle multiple projects with exceptional organizational and time management skills.
4. Proven track record in Project Management.
5. Proven track record with Medical Device, FDA regulations, ISO, cGMP and QMS standards
6. In-depth understanding of verification & validation (IQ,OQ,PQ) as well as risk analysis (FMEA)
7. Ability and willingness to travel up to 10%
8. PMP certification - NICE TO HAVE:
9. Experience with Visual Project Management - NICE TO HAVE:
10. Experience with turnkey, capital equipment - NICE TO HAVE:
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