This is a key technical leadership role with the responsibility of leading the development and execution of comprehensive testing strategies for client’s products. You will be responsible for evaluation, development, and implementation of test systems/tools/equipment, including design documentation. The position will provide Verification and Validation expertise to new product introduction of electro-mechanical, software controlled medical devices. This role requires a deep understanding of medical device systems, strong leadership abilities, and a passion for ensuring product quality and compliance with regulatory standards.

Company Profile

Client is a small to mid-sized interventional and diagnostic technology company.

Primary Responsibilities

• Lead the planning, design, and execution of system-level testing for medical devices, ensuring compliance with regulatory requirements (e.g., FDA, ISO), customer and business needs.
• Develop and implement test plans, protocols, and procedures to verify and validate product functionality, performance, and reliability.
• Analyze and interpret test data, identify issues, and drive root cause analysis and resolution.
• Provide leadership and execution of best test method practices as part of a project team.
• Collaborate with cross-functional team members to ensure alignment on testing objectives and deliverables.
• Design clean, easy to use test fixtures and user interfaces for test equipment that measures robustness of design, provide error-checking, collects data and gives user feedback for acceptance and/or failure.
• Create and maintain traceability of test cases to requirements.
• Support regulatory submissions and audits by providing technical expertise and documentation.
• Use critical thinking and technical knowledge to solve complex system interaction problems.
• Perform work in adherence to the company Quality Management System (QMS), including development and maintenance of documentation.
• Commit to fostering and driving an environment and work output based on continuous improvement.

Minimum Qualifications:

• Bachelor’s degree in engineering, or other scientific discipline, preferably electrical, mechanical, software, biomedical systems, control engineering
• 8+ years of experience in design verification
• Proven track record of leading and executing complex system-level tests for medical devices
• Experience in coordinating and working with external test labs
• Experience with electromechanical systems, sensors, control and data acquisition systems development
• Proven background in automated test system development
• Excellent communication and interpersonal skills, with the ability to work effectively in a collaborative team environment
• Strong analytical and problem-solving skills with the ability to troubleshoot complex system issues
• Experience creating test fixtures with Python and LabVIEW
• Ability to grow productive, trusting, and open relationships with functional partners
• High degree of organizational skills and high attention to detail
• Ability to handle multiple tasks and prioritize effectively
• Ability to work both independently and as part of a team
• Ability to develop protocols, conduct system tests and write reports
• Ability to select and use appropriate statistical techniques to design experiments and analyze data.
• Strong initiative, high energy, and passion about new technologies

Preferred Qualifications:

• Graduate degree in Engineering (EE, ME, SW or Systems Engineering) or another scientific discipline.
• 10+ years of design verification experience
• In-depth knowledge of medical device regulations and standards (e.g., FDA, ISO 13485, IEC 60601).
• Experience with test automation tools and software
• Proficient in programming languages such as C, Python, LabVIEW
• Project management experience and certification (e.g., PMP) is desirable
• Good understanding of production test equipment design issues such as user friendliness, serviceability, ruggedness and has implemented and transferred equipment to external suppliers for high-volume manufacturing
• Awareness and working knowledge of system-level constraints in all disciplines, including mechanical, electrical, human factors and software
• Knowledge of latest industry trends, emerging technologies, and regulatory changes to continuously improve testing methodologies

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