Operations Project Manager

Operations San Francisco, California


Description

The Operations Project Manager at Spire Health will serve as the hands on program manager for one of our most critical cross-disciplinary projects; launching the next generation of the Spire Health Tag.  

Responsibilities:

  • Set and communicate program objectives and priorities and identify risks and mitigation plans for an aggressive development schedule.
  • Interact, integrate, and drive results across cross-functional teams in engineering, manufacturing, supply chain, quality, sales, operations, etc.
  • Develop, maintain, and communicate the appropriate Program Plan ranging from when we will achieve high level objectives to specific release dates for development builds.
  • Ensure critical cross-team efforts are well owned (including owning some yourself) for optimal operations efficiency
  • Lead cross-functional Program and Manufacturing reviews discussing everything from scheduling to design to automation to IQ/OQ/PQ.
  • Ensure Design Control processes are followed and documented.
  • Engage with Med Device contract manufacturers on RFPs, Quality Plans, Process Development 
  • Continuously perform relevant risk and opportunity analyses to stay ahead of the game and address problems before they impact the program.
  • Provide clear updates at both working and executive level.
  • Create and refine processes and templates for things like change control, product development process, scheduling, risk tracking, etc. 

Qualifications:

  • A positive, can-do attitude
  • Experience shipping complex electromechanical systems or medical devices
  • The engineering experience to effectively lead technical programs
  • Past experience with fast-paced, high-growth environments like startups
  • An entrepreneurial disposition; you are able to creatively solve hard problems, get up to speed quickly, and bring curiosity to all the challenges you face
  • 5+ years experience in program management of medical device hardware and software systems
  • Bachelor’s or additional degrees in engineering or related fields
  • Multidisciplinary technical background – be comfortable in EE, ME and SW domains
  • Excellent computer skills, especially with communication tools and program management tools
  • Excellent written and verbal communication and presentation skills
  • Supply Chain Ops/Qualification experience
  • Experience of Manufacturing Equipment Automation and Validation - IQ/OQ/PQ
  • Experience with FDA GMP - knows about DMR, DHR, MFMEA 

Spire Health also provides additional benefits and is an Equal Opportunity Employer (M/F/V/D).