engineering Project Manager SAN JOSE, CA REF

Engineering Project Manager

Location: San Jose, CA

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.

Responsibilities

1. Oversee and drive multiple engineering projects of various sizes and complexities from initiation through validation and production release.
2. Responsible for developing realistic project schedules, along with resource planning, risk management, and measurable metrics to meet the project goals.
3. Communicate progress to stakeholders including the executive leadership team and provide recommendations for mitigating risks or delays.
4. Coordinate interdependent tasks and deliverables with key stakeholders including R&D Engineering, Manufacturing & Process Engineering, Facilities, EH&S, and Quality Assurance.
5. Lead and manage team meetings by creating agendas, presentations, minutes, and action items. Document team decisions and follow up on action items and deliverables.
6. Comply with company’s policies and guidelines regarding design control, validation activities, and documentation.

Qualifications

1. BS degree in engineering or a related technical field.
2. 7-10 years of experience managing engineering projects and using standard project management methodology, tools, and/or software packages.
3. The successful candidate will apply strong people and negotiation skills to plan, coordinate, and execute all relevant activities in a phase-gate setting.
4. Excellent interpersonal skills with an ability to communicate with people at all levels of the organization.
5. Strong leadership skills, self-motivated, and ability to influence others to achieve successful outcomes.
6. The position requires a high degree of adaptability, flexibility, creative decision-making, and technical problem-solving abilities.
7. Excellent verbal, written, presentation, and interpersonal skills.
8. Must be able to handle multiple projects with exceptional organizational and time management skills.
9. Proven experience using Project Management tools to manage complex project timelines as well as fluency with Excel, Word, PowerPoint, and Visio.
10. Proven track record with Medical Device, FDA regulations, ISO, cGMP, and QMS standards.
11. In-depth understanding of verification & validation (IQ, OQ, PQ) as well as risk analysis (FMEA).

Preferred Qualifications

1. PMP certification.
2. Experience with Visual Project Management.
3. Experience with turnkey, capital equipment.
4. Familiarity with sterilization processes and aseptic manufacturing.

Travel

Up to 10%