Principal Project Engineer
Core
Leading complex projects for the introduction and optimization of fully automated manufacturing lines for medical devices, specifically within third-party manufacturers.
Role type
Principal Project Engineer (Manufacturing Automation)
Builds
Automated manufacturing lines and major modifications to existing footprints for medical device products.
Domain
Medical Devices / Healthcare Manufacturing
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Project management, lifecycle management (design review to production ramp up), technical leadership, root cause analysis, statistical analysis, process documentation, equipment design review, vendor management, regulatory compliance (cGMP/FDA/ISO), problem solving, complex engineering studies.
Preferred skills
Automated manufacturing processes, Medical Device or Pharmaceutical environment, high-speed automation lines, design/commissioning/validation lifecycles, high-volume manufacturing, GAMP guidelines, measuring technology, pneumatics, electronics, vision systems, lasers.
Technologies
Automated manufacturing systems, equipment software, pneumatics, electronics, vision systems, lasers, GAMP guidelines
Responsibilities
Manage and implement major engineering projects for assembly of finished products; Drive activities at equipment suppliers for production start-up and scale-up; Provide technical leadership and project management for a team; Lead design, planning, and sustaining of automated manufacturing lines; Ensure project quality and adherence to policies; Report progress against timelines; Interface with product teams, R&D, Regulatory, and Quality personnel.
Seniority
Principal, hands-on IC with team leadership