Electrical Engineering Manager Medical Devices

Electrical Engineering Manager – Medical Devices

Key Responsibilities

• Provide technical and people leadership for Electrical Engineering teams supporting medical device R&D programs based in Irvine, CA
• Serve as the primary accountability owner for execution, quality, and delivery of offshore electrical engineering work supporting regulated medical products
• Translate system-level and product-level requirements from US-based R&D stakeholders into clear, actionable scope, priorities, and execution plans
• Manage staffing, capacity planning, task assignment, and workload balancing across multiple medical device programs
• Partner closely with Engineering, Program Management, Quality, Regulatory, Manufacturing, and Supplier teams to ensure compliant execution
• Oversee team contributions to:
• Sustaining engineering and post-market support
• Component obsolescence analysis and remediation
• Engineering Change Orders (ECOs) and design updates
• Design documentation, verification support, and risk management activities
• Ensure all team activities comply with medical device design controls, change management processes, and regulatory expectations (FDA, ISO)
• Review engineering deliverables at a system, requirements, and compliance level to ensure accuracy, completeness, and alignment with design intent
• Identify schedule, quality, compliance, or resourcing risks and proactively drive mitigation and resolution plans
• Drive continuous improvement in execution models, documentation quality, communication effectiveness, and regulatory readiness
• Coach, mentor, and develop engineers to build strong ownership, accountability, and medical-device-focused engineering discipline

Required Knowledge and Skills

• Strong foundational understanding of electrical engineering principles sufficient to lead and assess medical device hardware development and sustaining activities
• EDA / Design Tools - Altium Designer (schematic capture, PCB layout review)
• Experience guiding teams involved in analog and digital circuits, power electronics, and PCBA-based medical device designs
• Strong working knowledge of sustaining engineering, obsolescence management, and engineering change processes within regulated environments
• Solid understanding of medical device design controls, lifecycle documentation, and change management requirements
• Familiarity with medical device regulatory expectations including FDA 21 CFR Part 820, ISO 13485.
• Proven ability to lead and manage distributed engineering teams
• Strong execution, prioritization, and delivery focus in a multi-project medical device environment
• Excellent communication, interpersonal, and stakeholder management skills across cultures and time zones
• Ability to identify risk, make sound decisions, and drive execution with limited guidance

Optional Skills (Nice to Have)

• Experience supporting life-sustaining or critical-care medical devices (e.g., ventilators, infusion systems, monitoring equipment)
• Familiarity with IEC electrical safety and EMC standards (e.g., IEC 60601 series)
• Experience building or scaling medical device engineering teams
• Prior exposure to US FDA audits or regulatory inspections

Minimum Required Education and Experience

• Bachelor’s degree in Electrical Engineering or a related discipline
• 3 years of experience in electrical engineering for medical devices
• Minimum 1 years of experience working in the medical device industry (required)
• 1 years of experience leading, managing, or coordinating offshore or distributed engineering resources
• Prior people-management experience preferred but not strictly required

Employment Details

• Employment Type: Full time
• Employer: Silmates
• Role Focus: Leadership and management of electrical engineering teams supporting regulated medical device development
• Pay Rate: Competitive hourly rate based on experience.