The Association for the Advancement of Medical Instrumentation (AAMI) is the leading developer of medical device standards and the work we do drives medical device safety and improves patient outcomes. We bring together stakeholders from across the medical device ecosystem and our events, meetings, and forums are a critical component of AAMI’s ability to support our mission. We have proudly been in business since 1967.
Submit your resume to Employment@aami.org.
The Senior Director is responsible for ensuring policies and procedures are adhered to in assigned standards portfolio, including within the programs managed by their direct reports, resulting in high quality and consistent standards. This position also works closely with AAMI members, industry leaders, government representatives and subject matter experts (SMEs) across the field to develop standards and related products that solve challenges impacting multiple facets of the health technology/medical device industry.
Duties & Responsibilities
Oversee the AAMI Standards Board (SB) and its associated activities, including but not limited to:
Plan and execute meetings (in person and virtual) of the SB.
Lead the annual or biannual co-chair rotation management.
Consult with AAMI Standards staff on the development of new work item proposals (NWIPs) to ensure success at the Standards Board level; this includes reviewing forms and supporting documentation.
Monitor the growth of all standards program areas and work collaboratively with the SB and across the department to address potential challenges and opportunities.
Ensure that any strategic repositioning of the Standards Board and/or their responsibilities is communicated to the group and executed as envisioned by the head of the department.
Participate in the development and ensure implementation of consistency and quality control processes across the department, including but not limited to:
Develop plan and supporting process for conducting an annual AAMI self-audit in assigned standards portfolio.
Ensure that proper outreach is being carried out as required by AAMI and ANSI.
Ensure consistent high levels of data quality with regular analysis of the overall work in progress and publications as listed in the online standards platform to ensure that the information is current and accurate; this includes alignment with ANSI, ISO, and IEC records.
Utilize the standards development platform to track document development, identify bottlenecks, and additional areas for development.
Lead informational and internal training sessions with the entire Standards team to keep them apprised of changes to any policies and procedures that will affect the entire AAMI Standards program.
Develop and lead department quality improvement activities and initiatives pertaining to standards development processes.
Attend meetings/workshops (in person and virtually) led by ANSI/ISO/IEC to continuously stay apprised of changes in ANSI/ISO/IEC processes.
Train, lead, and mentor direct reports. Participate in the cross-training and onboarding of new staff as needed. Coordinate with Shared Services team lead to ensure that the work program is supported accordingly.
Work closely with and provide oversight as appropriate to committees and working groups in the development of national (AAMI, ANSI) and international (ISO/IEC) standards ensuring all relevant policies and procedures are followed.
Facilitate the maintenance, revision, and implementation of the AAMI TAG Procedures to IEC and ISO and related training materials (both internal and external).
Represent AAMI, its policies and values to all stakeholders at committee, working group and other relevant meetings as appropriate.
Responsible for tracking budget related to standards portfolio. Provide annual budget input as requested by head of department.
Collaborate with staff in Production, Innovation, IT, Marketing, Communications, and Education on the ongoing status of standards to ensure the appropriate and timely coordination of the production, promotion, and marketing of standards and related or derivative products.
Collaborate with membership in recruiting and retaining corporate members to achieve budgeted corporate membership revenue targets.
Respond to written, electronic mail, and telephone inquiries regarding standards
Develop and deliver internal and external communications, presentations, reports, articles, etc. as requested by VP or other AAMI staff
About Association for the Advancement of Medical Instrumentation
The Association for the Advancement of Medical Instrumentation® (AAMI) is a nonprofit organization founded in 1967. It is a diverse community of more than 9,000 professionals united by one important mission—the development, management, and use of safe and effective health technology. AAMI is the primary source of consensus standards, both national and international, for the medical device industry, as well as practical information, support, and guidance for healthcare technology and sterilization professionals.