Medical Device & Notified Bodies Test Lead

Job Title: Medical Device Test Engineer Director

Job Summary:
The Medical Device Test Engineer Director is responsible for overseeing the testing and validation of medical devices to ensure they meet regulatory standards and performance specifications. This role involves leading a team of engineers and technicians, developing test protocols, managing testing projects, and collaborating with cross-functional teams including R&D, quality assurance, and regulatory affairs.

Key Responsibilities:

Leadership and Management:
Lead and mentor a team of test engineers, technicians & middle management
Develop and implement strategic plans for the testing department.
Allocate resources effectively to meet project deadlines.

Test Planning and Execution:
Develop and oversee the execution of test protocols for medical devices.
Ensure comprehensive testing including performance, reliability, and safety.
Analyze test data, document findings, and provide recommendations.

Regulatory Compliance:
Ensure all testing activities comply with FDA, ISO 13485, ISO 60601 and other relevant standards.
Prepare and review documentation for regulatory submissions.
Stay updated on regulatory changes and implement necessary adjustments in testing processes.

Collaboration and Communication:
Work closely with R&D to integrate testing plans into the product development process.
Collaborate with quality assurance to ensure that all devices meet required standards.
Communicate test results and progress to senior management and other stakeholders.

Continuous Improvement:
Identify opportunities for process improvements in testing methodologies and equipment.
Implement best practices to enhance the efficiency and accuracy of testing processes.
Stay current with industry trends and advancements in medical device testing.

Required Qualifications:
Bachelor’s degree in Biomedical Engineering, Mechanical Engineering, Electrical Engineering, or a related field. Advanced degree preferred.
Minimum of 10 years of experience in medical device testing, with at least 5 years in a leadership role.
In-depth knowledge of FDA regulations, ISO 13485, and other relevant standards.
Proven experience in developing and executing test protocols for medical devices.
Strong analytical skills and proficiency in data analysis software.
Excellent leadership, communication, and project management skills.

Preferred Skills:
Experience with a wide range of medical devices, including both hardware and software components.
Familiarity with risk management processes in the medical device industry.
Ability to work in a fast-paced, dynamic environment and manage multiple projects simultaneously.
Certification in quality management or a related field (e.g., Six Sigma, ASQ).

Working Conditions:
This position may require occasional travel to meet with regulatory bodies, attend industry conferences, or visit manufacturing sites.
The role involves working in both office and laboratory environments, with adherence to safety protocols for handling medical devices and testing equipment.

Application Process:
Interested candidates should submit a resume and cover letter detailing their relevant experience and leadership approach. Applications can be sent to [email protected]

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