Norm Compliance and Laboratory Quality Engineer

Overview: In this role, you will work within a multi-disciplinary team to assess product safety aspects of MR RF coils and other hardware components with respect to design changes, perform IEC testing, and prepare test reports to demonstrate compliance with applicable international medical safety and EMC standards, including IEC 60601-1, IEC 60601-2-33, and IEC 60601-1-2. The role is also responsible for maintaining test equipment used within the BU organization, ensuring the accuracy of calibration records, conducting internal laboratory audits, and ensuring that equipment maintenance is performed as required in line with ISO/IEC 17025 requirements.

Key Roles and Responsibilities:

• Own end-to-end compliance testing activities from planning to report closure.

• Ensure that all lab records, calibration certificates, maintenance logs, and test documentation are maintained in an audit-ready state.

• Prepare, review, and maintain compliance test reports, technical justifications, and supporting documentation in accordance with applicable standards and quality requirements.

• Drive closure of corrective and preventive actions identified during internal audits.

• Coordinate with external test agencies, calibration service providers, and internal stakeholders to ensure timely completion of testing, calibration, and compliance deliverables.

Education: Bachelor of Engineering or Master of Engineering in Electrical, Electronics, Mechatronics Engineering, Biomedical Engineering or a related engineering discipline.

Qualifications:

• 5–8 years of experience in medical device testing, compliance, calibration, or lab quality management.

• Hands-on experience with IEC testing and technical documentation.

• Familiarity with ISO/IEC 17025 based lab practices.

Preferred Qualifications

• Experience working with external test agencies.

• Experience in medical electrical equipment, MRI systems, RF coils, or regulated healthcare product development is preferred.

• Internal auditor experience or QMS exposure.

Additional Skills:

• Strong documentation discipline.

• Audit readiness mindset.

• Ability to work with cross-functional engineering teams.

• Attention to regulatory detail.

• Proactive follow-up with external vendors and calibration partners.

Roles and Responsibilities
Under direct supervision, assists in the design, layout, testing, and evaluation of mechanical and electro-mechanical devices or systems. Performs product development activities including drawing board layout and interpretation and implementation of customer specifications and documentation requirements. Provides existing product line support in design activities and/or modification of hardware in production. Conducts engineering studies and may assign work to technical drafting staff.