Overview

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%