Support, liaise and consult with product management staff, extramural investigators, requirements generators, and regulatory support.
Assist biomedical engineers in managing the development of medical devices as they progress through the FDA clearance/approval process, and the DOD medical acquisition development pipeline, to include an understanding of the JCIDS process.
Serve as an independent subject matter expert to assess proposals, programs and development progress of the devices within the assigned portfolio.
Conduct market analysis to include available products and industries, gain an understanding of product market survivability and viability as a crucial component for the execution of force-wide fielding.
Participate and actively engage on Integrated Product Teams (IPT) as a Chartered Member and serve as the technical expert by providing expert advice and working closely with the IPT in developing plans and protocols for clinical studies, parameters for the market research, Analysis of Alternatives study plans, acquisition strategies.
Assist with the development of and/or review clinical study-related documents, such as the Investigator s Brochure, informed consent documents, case report forms, recruitment materials, subject training documents, diary cards, study specific procedures, and source documents, clinical monitoring plans, data management plans, safety management plans, etc, to ensure conformity with the clinical protocol.
Work with the clinical trial monitor and clinical sites to ensure all necessary approvals (e.g., Sponsor, IRB), training, procedures, and equipment are in place prior to study start.
Review test plans, and results and reports from clinical studies and other testing, to include the review of the final study reports at the end of each phase of a clinical study, and/or lab results from testing facility.
Inform the IPT of significant developments pertaining to clinical studies, sites or clinical support, as well as issues related to product testing and validation, clinical trial progress, monitor findings, and/or results in light of product development plans.
Align appropriate program element against appropriate lifecycle category for work planned; track appropriate budget, commitment, obligation, and expenditures; and analyze funding expended against funding commitments, communicate any changes in cost, schedule, and performance to the PdM.
Assist the PdM in the review of regular POM cycles, spend plans, cost estimating and other cost analysis requirements.
Assist in developing, preparing, managing, and writing documentation requirements to include Executive Summaries (EXSUMS), Acquisition Decision Memorandums, White Papers, briefings, and information papers on the subject matter, and adhere to required pre-brief schedules for all documentation leaving the Command.
Monitor, track, and report breaches in the Acquisition Program baselines and assist in the development and implementation of maintenance support strategies for new devices in the portfolio.
Serve as a contributing member of a team comprised of field technicians, local staff technicians, healthcare administrators, and product developers.