Travel Requirements: This position may require up to 25% travel.
Application Period: Thursday, July 8, 2021, through Friday, August 6, 2021
Salary: Salary is commensurate with education and experience (see below)
Conditions of Employment: U.S. Citizenship or permanent U.S. residency is required
Introduction: The Center for Devices and Radiological Health (CDRH or Center) assures that patients and providers have timely and continued access to safe, effective, and high-quality medical devices and safe radiation-emitting products. CDRH facilitates medical device innovation by advancing regulatory science, providing industry with predictable, consistent, transparent, and efficient regulatory pathways, and assuring consumer confidence in devices marketed in the U.S.
Within CDRH, the Office of Strategic Partnerships and Technology Innovation (OST or Office) provides leadership for all scientific, collaborative, and emerging technology related activities at the Center. OST represents the Center and collaborates with a broad and diverse array of national and international entities including other government agencies, Congress, industry, academia, consumer and patient organizations, and healthcare professional organizations, with mutual interests in medical devices and radiation-emitting products.
Shortages in medical devices can present a substantial threat to the nation’s public health infrastructure. Specifically, interruptions in medical device supply chains can obstruct and prevent the provision of lifesaving and life-sustaining care to patients. As such, OST has established a Resilient Supply Chain and Shortages Prevention Program (RSCSPP or Program). This Program will develop innovative and effective national strategies, in collaboration with industry, as well as public and private stakeholders, to ensure adequate inventories of safe, effective, and reliable, medical devices and products are available and accessible for patients who need them.
Position Summary: CDRH is seeking a dynamic, innovative, and experienced Supply Chain Expert. Reporting to the Director of the Resilient Supply Chain and Shortages Prevention Program, you will be responsible for leading and managing medical device supply chain activities. If selected, in coordination with Centers across the Agency, you will develop and establish medical device shortage mitigation measures to address actual and potential vulnerabilities in the nation’s medical device supply chain. You will also analyze current supply chain systems, safeguards, and methodologies to address all existing and/or conceivable weaknesses, knowledge gaps and risks factors. You will present concepts for the formulation of more robust reporting tools to alert multiple levels of leadership and institute more comprehensive countermeasures designed to avert shocks and disruptions to supply chains.
Duties/Responsibilities: As the Supply Chain Expert you will:
Serve as the Center’s foremost expert on medical device supply chain management and provide authoritative, sound, and evidence-based information to ensure the sustained availability of medical devices during times of calm and public health emergencies, both natural and man-made.
Utilize expert supply chain knowledge, risk mitigation expertise, and management experience to advance the Center’s medical device supply chain program and serve as an Agency expert on cross-functional teams for both the Center and Agency.
Lead efforts in supply chain illumination, problem solving, and analytics to support and enhance the safety, effectiveness, and quality of medical devices.
Collaborate with Agency colleagues to share and leverage medical device supply chain resources, knowledge, benchmarks, and best practices.
Evaluate the causation of various supply chain shocks and develop and share mitigation strategies across the Center and Agency, as well as with industry, suppliers, contract manufacturers, distributors, and other stakeholders to stem potential disruptions.
Draft recommendations to address supply chain vulnerabilities and risks, which could lead to potential disruptions.
Forge mutually beneficial formal partnerships with medical device manufacturers, suppliers, carriers, scientific associations, organizations, and societies, health care community, patient advocacy groups, and other federal, state, and local stakeholders regarding the safe, manufacturing, production, availability, and delivery of medical devices.
Conduct analyses of existing technologies in comparison with needed capabilities to support medical device supply chain data analytics implementation.
Provide expert guidance and share recommendations on cloud-based solutions and custom software to support supply chain business technology integration needs.
Collaborate with Center colleagues to define and develop metrics to measure goals and outcomes of the supply chain program.
Continuously evaluate the performance and impact of the Center’s supply chain program and research new and emerging technologies to enhance and advance data collection and programmatic goals and objectives.
Professional Experience/Key Requirements: To qualify for this position, you must demonstrate in your resume the necessary qualifying experience for this position, which includes the following:
Solution focused expert supply chain professional with superior project management and highly effective communication skills who can successfully direct and manage large multi-factorial and long-range initiatives of national significance.
Experience in evaluating, developing medical device supply chains across large and complex scientific and regulatory organizations.
Expertise in evaluating national and global medical device supply chains and identifying factors to improve efficiencies, reduce costs, and mitigate vulnerabilities and potential disruptions.
Expertise in developing evidenced and risk-based solutions regarding disaster recovery plans and developing optimal, secure, and agile supply chain networks.
Wide-ranging technical expertise in medical device supply chain network infrastructure development and implementation, business analytics and modeling.
Prior experience in a scientific, regulatory, or medical device manufacturing setting.
Ability to work collaboratively with a diverse cadre of colleagues and stakeholders in a continuous quality improvement environment.
Ability to manage multiple projects and effectively lead and develop employees.
Basic Qualifications: In order to qualify for this position, you must meet the educational requirements outlined in the Office of Personnel Management (OPM) Qualification Standards for one of the below occupational series. To view the educational requirements for each professional series and to learn if you qualify, please select the corresponding hyperlink for your particular course(s) of study from the options below:
Position Levels: This position will be filled at the GS – 13, which has a corresponding salary range of $103,690 to $134,798 or GS -14, with a corresponding salary range of $122,530 to $159,286, based on knowledge and experience.
All applicants born male, on (or after) 12/31/1959, must be registered with the Selective Service System OR have an approved exemption.
This position is subject to strict prohibited financial interest regulations which could restrict the type of financial interest (stock holdings) for the employee, the spouse, and minor children of the employee. For additional information on the prohibited financial interests, visit the FDA Ethics and Integrity Office website at https://www.fda.gov/about-fda/jobs-and-training-fda/ethics.
How to Apply: Submit an electronic resume or curriculum vitae, cover letter containing a brief summary of scientific accomplishments, SF-50 (if applicable), and a copy of unofficial transcripts all in one document (Adobe PDF) to CDRHRecruitment@fda.hhs.gov, with Job Reference code “2020-OST-Supply Chain-00T” in the subject line. Applications will be accepted through August 6, 2021.
The Department of Health and Human Services is an equal opportunity employer with a smoke free environment.
FDA is an equal opportunity employer
Additional Salary Information: This position will be filled at the GS – 13, which has a corresponding salary range of $103,690 to $134,798 or GS -14, with a corresponding salary range of $122,530 to $159,286, based on knowledge and experience.
About U.S Food and Drug Administration, Center for Devices and Radiological Health
The mission of the Center for Devices and Radiological Health (CDRH) is to protect and promote the public health. We assure that patients and providers have timely and continued access to safe, effective, and high-quality medical devices and safe radiation-emitting products. We provide consumers, patients, their caregivers, and providers with understandable and accessible science-based information about the products we oversee. We facilitate medical device innovation by advancing regulatory science, providing industry with predictable, consistent, transparent, and efficient regulatory pathways, and assuring consumer confidence in devices marketed in the U.S.