Medical Device Testing Specialist (On-Site)

• Long Term Contact or Contract to hire
• Must be on site in Marlborough MA
• No relocation

A Medical Device Testing Specialist plays a crucial role in ensuring the safety, efficacy, and compliance of Medical Devices before they reach the market. This position involves designing, implementing, and overseeing testing protocols to assess the performance, reliability, and regulatory adherence of Medical Devices. The specialist collaborates with cross-functional teams, including engineers, quality assurance professionals, and regulatory affairs experts, to contribute to the development of safe and effective Medical Devices.

Responsibilities:

Test Protocol Development:

• Design and develop comprehensive testing protocols based on regulatory requirements and industry standards.
• Collaborate with engineering teams to understand device specifications and user requirements.

Testing Execution:

• Conduct testing activities according to established protocols, including functional, performance, reliability, and safety testing.
• Utilize specialized testing equipment and tools to simulate real-world usage conditions.

Data Collection and Analysis:

• Collect, organize, and analyze test data to evaluate the performance and safety of Medical Devices.
• Prepare detailed reports documenting test results, observations, and any deviations from expected outcomes.

Regulatory Compliance:

• Stay current with relevant regulatory requirements and standards (e.g., FDA, ISO) to ensure testing protocols align with regulatory expectations.
• Collaborate with regulatory affairs teams to provide necessary documentation for regulatory submissions.

Collaboration:

• Work closely with cross-functional teams, including product development, quality assurance, and regulatory affairs, to address issues and improve product design.
• Participate in design reviews to identify potential areas of concern related to testing.

Continuous Improvement:

• Identify opportunities for process improvement within the testing procedures.
• Stay informed about advancements in testing methodologies and technologies relevant to Medical Devices.

Documentation:

• Maintain accurate and detailed records of testing activities, results, and any modifications to testing protocols.
• Ensure documentation complies with quality system requirements.

Training and Mentorship:

• Provide guidance and mentorship to junior team members.
• Conduct training sessions on testing procedures and best practices.

Qualifications:

• Bachelor's or Master's degree in biomedical engineering, electrical engineering, or a related field.
• Solid understanding of Medical Device regulations, standards, and quality systems.
• Experience in designing and conducting Medical Device Testing protocols.
• Proficient in using testing equipment and tools.
• Strong analytical and problem-solving skills.
• Excellent communication skills, both written and verbal.
• Attention to detail and the ability to work independently and as part of a team.