Responsible for managing a company compliance engineering program that results in compliant products having the required certifications within time frames that meet new and sustaining program goals.
• Establish program(s) within engineering and other departments to ensure design compliance with IEC 60601-1 safety standards including general safety, system safety, ultrasound safety, EMC, and biocompatibility.
• With manufacturing, establish a program to ensure design compliance with the RoHS Directive, related environmental laws, and IEC 60601-1-9, Requirements for Environmentally Conscious Design.
• Provide planning and scheduling of compliance engineering activities to program management.
• Maintain in-house test capability for demonstrating compliance to IEC 60601-1 general safety and system safety that meets CSA SMT requirements. Provide proposal, planning, and implementation for in-house EMC testing prior to external testing.
• Test new and sustaining products to applicable IEC 60601-1 safety standards. Coordinate external EMC and biocompatibility testing.
• Create test reports and documentation (CSA format) that will be accepted by CSA for UL/CSA/ CB approval.
• Obtain other safety approvals, as required to support market requirements. Provide support for submissions made by Regulatory Affairs.
• Release compliance verification plans and reports showing that applicable FRS requirements are met for general safety, system safety, ultrasound safety, EMC, and biocompatibility.
• Provide leadership, planning, coordination, and implementation for meeting revisions of standards or new standards, such as the 3rd edition of IEC 60601-1.
• Assist in technical risk management and assessment.
Required Knowledge Skills & Abilities:
• BS Engineering or Physics.
• 10+ yrs in compliance or test engineering. Knowledge and test experience with respect to IEC 60601-1 medical equipment safety standards including general safety, system safety, and EMC is strongly preferred.
• 2+ years leadership role working with line departments in a manufacturing environment.
• ISO, FDA, or other regulated industry training and experience.
• Risk assessment experience.
• Excellent written and oral communication skills.
• Able to provide either leadership or a supportive role within a project team.
• Able to coordinate and manage multiple tasks simultaneously.
• Familiarity with MS Project and Agile Change Management strongly preferred.
• Ability to lift a minimum of 25lbs with or without accommodations.
SonoSite is an equal opportunity employer and strongly supports diversity in the workplace.
SonoSite Inc. - 18 months ago