DNV Supply Chain and Product Assurance has immediate openings on our growing Medical Device Team!

DNV Supply Chain and Product Assurance is looking to recruit technical and experienced personnel to be Active Medical Device Assessors throughout North America with expertise specific to stand-alone software and/or medical devices controlled by software. This position can be remote from anywhere in the Continental U.S.A.

The successful candidate(s) will be responsible for conducting product reviews of client technical documentation, in accordance with the Medical Device Regulation (EU 2017/745), enabling the delivery of certification services that meet customer requirements and appropriate accreditation standards.

Job Summary:

Individuals in this role must have successfully completed a university or technical college degree in the following or similar degree fields: Biomedical Engineering, Mechanical Engineering, Electrical / Electronics Engineering, Computer / Software Engineering or Medical Technology.

This role requires 4-years of professional experience working in the medical device industry, in the field of healthcare products or related activities. Professional experience must include at least 2-years in the design, manufacture, testing or use of the medical device or technology to be assessed or related to the scientific aspects to be assessed.

The successful candidate possesses knowledge and understanding covering a wide range of medical device technologies and hands-on experience in the development, manufacturing / programming, testing and validation of active medical devices, medical device software and / or medical devices controlled by software.

What You'll Do:

• Assess / review client's technical documentation / medical device files against the Medical Device Regulation [EU 2017/745].
• Interact directly with customers at all levels of management in developing timely, complete, and accurate reports of their current level of compliance and implementation of their technical documentation.
• Document and report assessment activities and results utilizing analytical skills, technical knowledge, and excellent written communication skills.
• Provide timely and accurate reviews of customer corrective actions.
• Conduct assessments in accordance with established procedures, maintaining a high standard of service delivery that ensures effective customer relationships.
• Conduct Technical Documentation reviews specific to products being authorized.
• Analyze complex regulatory requirements and make sound determinations of the proper course of action.
• Work with minimal supervision with the ability to assess compliance to regulatory requirements.
• Work independently or within a team environment utilizing positive interactive skills.
• Maintain appropriate assessor credentials and pursue advancement of those credentials and other related credentials as needed.
• Complete all chargeable work within the required budget and timeframes to ensure customer satisfaction and efficiency of the business.