Product Safety Engineer

A strong background in safety engineering, including relevant standards and hands on experience.

 Minimum 10+ years of compliance related experience of medical devices

 Experience in developing and executing validation and verification plans.

 Strong knowledge of regulatory standards and governmental regulations (UL, CSA, CE, BIS, IEC 61010, IEC 60601, IEC 62368, IEC 61326 etc.)

 Operate comfortably in a fast-paced environment with regularly shifting priorities.

 Manage multiple projects simultaneously while maintaining exceptional attention to details.

 Ability to travel up to 10%.

 Produce and coordinate the development and update of internal/external technical documentation.

 Independently conduct evaluation of products to determine compliance with applicable standards.

 Collaborate with engineering planning and design change teams.

 Ensure critical components are approved to or meet regulatory requirements.

 Develop and execute validation and verification plans.

 Interface with certification authorities, and test laboratories.

 Oversee Safety, EMC and RF testing at the product level.

 Assure that all activities related to product certification commence and execute as planned.

 Ensure that all regional requirements are met and that product designs employ appropriate safety risk mitigation solutions.

 Lead failure analysis of safety / compliance testing and coordinate with the R&D design team to implement design changes.

 Contribute to continuous improvement initiatives by leading compliance investigations and CAPAs.

 Establish compliance plans for new products