Lead Medical Product Management Specialist

Role Description: Provide Program/Project Management Support to USAMMDA in the day-to-day medical product development activities according to U.S. Army, USAMRDC, USAMMDA, and DoD acquisition policies and regulations. Incumbent will provide internal consulting capability in addition to the performance of medical product and device product manager duties. Incumbent will support a government Project Manager and Deputy Project Manager and will be supported by more senior Deloitte practitioners to provide guidance and oversight. Specific functions include the following

i. a. Support the organization in the day-to-day medical product development activities to include participation in Integrated Product Team, Working Group, Product Lifecycle Review Committee and Investigator meetings as well as other meetings that are part of the acquisition process.

ii. b. Serve as a senior management, acquisition, and technical advisor to the PjM, Deputy PjM and PdMs.

iii. c. Supervise, mentor, and develop junior contract staff within the WHPE PMO

iv. d. Assist Integrated Product Teams entering, navigating, and understanding the unique requirements of the Defense Acquisition System, as well as the associated USAMRDC and DHA DAS management and oversight processes (i.e., USAMRDC Decision Gate process or DHA equivalent). Apply DoDI 5000.02 and associated instructions

v. e. Coordinate the conduct of development testing as well as support and coordinate operational assessment and testing, to include delivery of test items such as test articles and manuals.

vi. f. Assist teams in developing required acquisition program information and documentation in accordance with USAMRDC, Army, DHA, and DoD policies, regulations and guidance. This may include authoring draft documents for teams or reviewing and providing constructive recommendations for improvement back to the teams regarding documents they authored. Documentation includes but is not limited to Simplified Acquisition Management Plan, Market Research Reports, Analysis of Alternatives, Business Case Analysis, Lifecycle Cost Estimate, Test and Evaluation Master Plan, Life Cycle Sustainment Plan and decision gate briefings

vii. g. Monitor program progress against approved schedules, budgets, and capabilities

viii. a. Identify risks and issues and work with vendors and internal and external stakeholders to keep the program on-track

ix. h. Communicate and coordinate with internal and external stakeholders to meet program objectives and document their coordination.

x. i. Provide support for all testing as well as FDA and non-FDA regulated events.

xi. j. Conduct market research, support analyses, review existing tech base programs, and recommend acquisition strategies to strengthen and engage medical requirements and/or medical capabilities in support of force health protection and provide information packages based on the results of these analyses.

xii. k. Provide the capability of integrating the DoD Acquisition processes with the FDA regulatory processes

xiii. l. Conduct market research, support analyses, review existing tech base programs, and recommend acquisition strategies to strengthen and engage medical requirements and/or medical capabilities in support of force health protection and provide information packages based on the results of these analyses. Participate in task forces and surveys, studies, and other investigations of areas of management operations to determine adequacy of medical equipment. Support the management and execution of product evaluations and responses for the New Products and Ideas submissions.

xiv. 2. Competencies

xv. a. Required

xvi. i. Ability to manage product development through the Adaptive Acquisition Framework (as in DoDI 5000.02)

xvii. ii. Expertise in FDA regulatory requirements related to medical device development

xviii. iii. Capability to utilize MS Office at an intermediate or advanced level

xix. iv. Outstanding communicator both verbal and written; ability to effectively communicate and coordinate with multiple internal and external stakeholders

xx. v. Ability to communicate with military Senior Leaders (SES & O7-O9), to include developing and presenting briefings and recommendations

xxi. vi. Ability to work with minimal oversight and develop and mentor more junior practitioners

xxii. b. Preferred

xxiii. i. Broad understanding of the DoD medical research, development, and acquisition processes from discovery through fielding

xxiv. ii. Knowledge of document development for Business Case Analysis, Strategy Plans, Integrated Program Summary, Life Cycle Cost Estimates, Test and Evaluation Master Plans and operating and maintenance instructions

xxv. iii. Ability to apply FDA regulations to DoD development

xxvi. 3. Experience

1

Requirements

1Education and Training

a. Required

i. Bachelor s degree in a biomedical engineering, mechanical engineering, biology or similar

ii. DAWIA Program Management - Practitioner (or the former DAWIA PM Level II) and/or PMP

16+ years experience working in DoD or Commercial life science product development

Preferred

Experience supporting a PdM, PjM, or PM in an Army PEO or a JPEO

Benefits