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Engineering Program Manager

2 months ago

San Jose, California, United States ESR Healthcare Full time
Position Overview

We are looking for a seasoned Project Manager to oversee the successful execution and launch of engineering initiatives within a dynamic setting.

Key Responsibilities
  • Manage and drive multiple engineering projects of varying complexity from inception through validation and production release.
  • Develop realistic project timelines, resource allocation, risk management strategies, and measurable metrics to achieve project objectives.
  • Communicate project progress to stakeholders, including executive leadership, and provide recommendations for addressing risks or delays.
  • Coordinate interdependent tasks and deliverables with essential stakeholders, including R&D Engineering, Manufacturing, Facilities, and Quality Assurance.
  • Lead team meetings by preparing agendas, presentations, minutes, and action items. Document decisions and follow up on deliverables.
  • Ensure compliance with company policies and guidelines regarding design control, validation activities, and documentation.
Qualifications
  • Bachelor's degree in engineering or a related technical discipline.
  • 7-10 years of experience managing engineering projects and utilizing standard project management methodologies, tools, and software.
  • Strong interpersonal and negotiation skills to effectively plan, coordinate, and execute activities in a phase-gate environment.
  • Excellent leadership abilities, self-motivated, and capable of influencing others to achieve successful outcomes.
  • High adaptability, flexibility, creative decision-making, and technical problem-solving skills.
  • Outstanding verbal, written, presentation, and interpersonal communication skills.
  • Ability to manage multiple projects with exceptional organizational and time management skills.
  • Proficient in using Project Management tools to oversee complex project timelines, along with fluency in Excel, Word, PowerPoint, and Visio.
  • Demonstrated experience with Medical Device regulations, FDA compliance, ISO standards, cGMP, and QMS.
  • In-depth knowledge of verification & validation processes (IQ, OQ, PQ) and risk analysis (FMEA).
Preferred Qualifications
  • PMP certification.
  • Experience with Visual Project Management.
  • Familiarity with turnkey capital equipment.
  • Understanding of sterilization processes and aseptic manufacturing.
Travel Requirements

Up to 10% travel may be required.