ICON plc is a world-leading healthcare intelligence and clinical research organization. From molecule to medicine, we advance clinical research providing outsourced services to pharmaceutical, biotechnology, medical device and government and public health organizations. With our patients at the center of all that we do, we help to accelerate the development of drugs and devices that save lives and improve quality of life. Our people are our greatest strength, are at the core of our culture, and the driving force behind our success. ICON people have a mission to succeed and a passion that ensures what we do, we do well.
ICON Government and Public Health Solutions (IGP) is a full-service CRO specializing in preclinical through phase IV support of clinical research and clinical trial services for biologics, drugs, and devices. We help our customers get their products to market faster with an array of research, regulatory, and sponsor services. Globally, we respond rapidly to health crises and serve where few others do. We create a unique synergy in the global market, with projects spanning the government, academic, and commercial sectors. ICON Government and Public Health Solutions has a distinct ability to provide rapid response efforts to global health crises.
IGP is recruiting for a Senior Biomedical Engineer/Systems Engineer/Product Manager to assist our government customer with supporting the medical Research, Development, Test, and Evaluation (RDT&E) as well as fielding and deployment phases of the acquisition life cycle for devices, equipment, and systems used on the battlefield. The position is based in Frederick, MD.
DUTIES AND RESPONSIBILITIES:
The experienced, professional, and dynamic Senior Biomedical Engineer/Systems Engineer/Product Manager will assist with a variety of products and programs and perform the following duties:
- Work with Project/Product Managers, Logistics Managers, other Engineers, and End-Users to provide Life Cycle support for multiple medical and non-medical products, programs, and systems.
- Coordinate with a large network of matrixed organizations within the DoD, US Army, and other Federal agencies to ensure effective, efficient, and timely completion of the medical product development mission.
- Participate in Integrated Production Teams (IPTs), working groups, and other meetings including preparing meeting agendas and minutes, managing participation, and tracking action items.
- Prepare and maintain project management integrated master schedules, Gantt charts, and action item lists for assigned programs according to project management best practices and DoD guidelines to monitor program progress.
- Edit and maintain technical, budget, programmatic, administrative, and acquisition milestone documentation, to include program briefings IAW applicable DoD 5000 series regulations to ensure successful decision reviews, such as Business Case Analysis (BCA), Strategy Plans, Integrated Program Summary, Life Cycle Cost Estimates (LCCEs), Test and Evaluation Master Plans (TEMPs), and operating and maintenance instructions consider elements such as reliability, maintainability, availability, and cybersecurity (Risk Management Framework).
- Manage the lifecycle of medical products and assemblages (Sets, Kits, and Outfits (SKOs)), to include fielding and sustainment; coordinate with other directorates and outside agencies to formally transition items through the lifecycle, to include transition to sustainment.
- Manage configuration control, ensure successful integration and interoperability, and champion life-cycle management of products by building IPT partnerships with other DoD organizations.
- Provide technical input, build slides, and draft documents (e.g. Life Cycle Sustainment Plans (LCSPs), Maintenance Support Plans, and Sustainment Strategies) to support acquisition presentations and documentation in support of major milestones, program reviews, and major leadership decisions.
- Participate in the engineering requirements generation process with external Army organizations.
- Conduct a systems analysis to include communications interface, data modeling, systems security, information assurance, patient privacy, and program assessment to support integration planning and systems program management.
- Assist in the development of contract documentation to include but not limited to market research, acquisition strategy, Performance Work Statement, cost estimate, purchase request, justification & approval, or other program presentations.
- Develop systems engineering, program, and acquisition documentation in support of major acquisition decisions for assigned products and assemblages, as required.
- Develop and implement a system engineering management process to guide the development and management of a requirements-driven architecture through the entire system engineering life cycle for assigned products and assemblages.
- Develop and manage a test program that is consistent and aligns with the Test and Evaluation Master Plan (TEMP) for assigned products, compile test plans, processes, objectives, results, and other documentation.
- Analyze assigned products and assemblages tracking issues, complaints, safety alerts, equipment recalls, and prepare documents drafting recommendations and proposed courses of action.
- Lead Contractor site visits, monitor performance and quality standards, and provide technical oversight during all life cycle management phases.
- Analyze medical equipment based on maintenance data, usage data, technology standards, and life cycle data.
- Maintain knowledge and usage in the Army’s web-based applications used to manage the life cycle of major items of equipment (such as Cloud Equipping (cQuiP) program, formerly known as the Standard Study Number-Line-Item Number Automated Management and Integrating System (SLAMIS)).
- Support fielding of managed products to include confirming the receipt of end items, non-expendables, durables, expendables, and the support packages at the gaining installation ensuring equipment accountability.
- Prepare and deliver a Materiel Fielding After Action Report (AAR) upon completion of each fielding mission to include a summary of events, all issues/concerns encountered, and corrective actions taken.
- Assist with cost analysis/estimates, budget management and execution, life cycle cost estimates, and tracking of product/program finances.
- Participate in special projects as required.
EDUCATION, SKILLS, AND EXPERIENCE REQUIRED:
- Bachelor’s degree in Biomedical/Clinical/Systems Engineering or in a related technical/scientific field or combination of related experience and education
- At least 5 years of related experience and 10 years of working experience; management/leadership experience desired
- Knowledge of military/Army medical devices/systems; understanding of systems engineering concepts as well as life cycle management principles
- Excellent communications, writing, organizational and project management skills; PMP certification desired
- SharePoint and MS Project experience desired
- Experience, knowledge, and the ability to execute using Microsoft Office Suite, Word, PowerPoint, and Excel, as well as Microsoft Outlook
- At least 2-3 years’ experience in Federal contracting, government or military environment is preferred.
- Travel up to 25% of the time may be required
- Public Trust T1-NACI Clearance Required
- US Citizen
- Must be able to pass background and drug testing.
- THIS IS A FEDERAL CONTRACT.
Benefits of Working in ICON:
Our success depends on the knowledge, capabilities and quality of our people. That’s why we are committed to developing our employees in a continuous learning culture – one where we challenge you with engaging work and where every experience adds to your professional development.
At ICON, our focus is to provide you with a comprehensive and competitive total reward package that comprises, not only an excellent level of base pay, but also a wide range of variable pay and recognition programs. In addition, our best in class employee benefits, supportive policies and wellbeing initiatives are tailored to support you and your family at all stages of your career - both now, and into the future.
ICON, including subsidiaries, is an equal opportunity and inclusive employer and is committed to providing a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.
If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please let us know.
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