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Engineering Laboratory Manager

1 week, 3 days ago
United States
Full-time
Lead
Operations Manager
Operations
Apply Now
Cadwell

Cadwell

Cadwell provides cutting-edge neurodiagnostic and neuromonitoring equipment with market-leading customer support, empowering healthcare professionals to broaden their expertise in EMG, NCS, and NMUS.

Health Care Providers & Services
51-250
Founded 1979
View All Jobs 3

Description

  • Lead the Engineering Laboratory team supporting new product development and post-release sustaining activities for medical devices.
  • Oversee failure analysis, design verification testing, component management, production and procurement support, and design improvements.
  • Provide mentorship and technical guidance to Laboratory Technicians and Engineers, supporting their growth and development.
  • Manage laboratory resources, workload, priorities, and schedules to meet project and support needs.
  • Resolve engineering support escalations from internal teams and external vendors in a timely manner.
  • Lead engineering change control for released designs and coordinate with Production, Procurement, and Manufacturing Engineering.
  • Own and improve laboratory standards, processes, checklists, and tools used by the team.
  • Monitor team performance and ensure work quality aligns with Cadwell design standards and industry best practices.
  • Partner cross-functionally with Procurement, Manufacturing, Service, Software and Hardware Engineering, Regulatory Affairs, Quality Assurance, and Supplier Quality Engineering.
  • Ensure team processes, training, and outputs comply with FDA 21 CFR Part 820, ISO 13485, Cadwell processes, and audit requirements.

Requirements

  • B.S. in Electrical Engineering or equivalent work experience.
  • 10+ years of relevant professional or technical engineering management experience with increasing responsibility.
  • Experience designing regulated equipment, ideally in the medical device or another highly regulated industry.
  • Comprehensive knowledge of engineering team leadership and development of procedures, checklists, and work instructions.
  • Comprehensive knowledge of PCB design from concept through manufacturing transfer and post-release support, including DFM/DFT analysis.
  • Thorough knowledge of electrical engineering principles, including failure analysis, reliability engineering, component selection, and risk-based decision making.
  • Thorough knowledge of common embedded electronic circuits such as DC-DC converters, embedded microcontrollers, memory interfaces, sensors, and related technologies.
  • Thorough knowledge of regulatory compliance and Quality Management Systems required for medical devices.
  • Thorough knowledge of the hardware development life cycle, including development, testing, change control, deployment to production, and maintenance.
  • Ability to plan, organize, communicate schedules, lead employees, manage risk, and collaborate across teams.
  • Ability to work outside normal business hours when needed and to travel if required.

Benefits

  • Competitive salary of $140,000 to $165,000 USD.
  • Equal opportunity employer with accommodation support for applicants who need assistance.
  • Potential for travel as part of the role, with travel document support implied by role requirements.
  • Opportunity to work on cutting-edge medical devices and support both development and sustaining engineering.

Interested in this position?

Apply directly on the company website

Apply Now

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