Overview
On Site
Full Time
Skills
Hardware QA
Collaboration
Regulatory Compliance
Functional Requirements
Risk Analysis
Design Review
Product Development
Electrical Engineering
Biomedical Engineering
Computer Hardware
Testing
Medical Devices
Customer Engagement
Management
Sourcing
Analytical Skill
Conflict Resolution
Problem Solving
Communication
ISO 13485
Embedded Systems
System Integration
Risk Management
ISO 9000
Attention To Detail
Documentation
Job Details
Responsibilities:
- Perform hardware functional verification and testing.
- Develop and update hardware test protocols for medical device hardware components.
- Perform design specifications review and approval for new and existing medical devices.
- Identify and validate alternative components to address obsolescence issues in medical device hardware.
- Collaborate with cross-functional teams to ensure compliance with regulatory standards and quality requirements.
- Contribute to risk analysis and management processes for medical device hardware.
- Participate in design reviews and provide technical expertise throughout the product development life cycle.
- Conduct IEC 60601 and other certification testing for medical electrical equipment.
- Bachelor's degree in electrical engineering, Biomedical Engineering, or related field.
- 5 to 7 years of experience in hardware engineering for medical devices.
- In-depth knowledge of IEC 60601 standards and testing procedures.
- Familiarity with medical device regulatory requirements (e.g., FDA, CE marking).
- Experience with obsolescence management and component sourcing for long-lifecycle products.
- Strong analytical and problem-solving skillsExcellent communication and documentation abilities.
- Knowledge of ISO 13485 and FDA Quality System Regulation.
- Experience with embedded systems and software-hardware integration.
- Familiarity with risk management (ISO 14971) standards.
- Attention to detail and commitment to quality.
- Ability to work independently and as part of a team.
- documentation skills.
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