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 

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%