Job Title: Medical Device Expert - Process Advisor IV

Established in 2001, The Tauri Group is a professional services firm known for our analytic rigor, practical solutions, and trusted advice in the areas of CBRN threat mitigation, defense science and technology, homeland security, and adjacent domains. We offer the financial stability and breadth of capability of a large company coupled with the corporate commitment and attention of a small firm. Our subject matter expertise, determination, agility, and commitment to active and ongoing client and stakeholder engagement enable us to solve tough problems and deliver results-oriented solutions that help our customers achieve mission success. We tackle our clients' most challenging problems by combining analytical rigor with world-class expertise and relevant operational experience. At The Tauri Group, we do what's right for the Program, the Mission, and the Nation.

We are seeking a Medical Device Engineer and Advisor with experience evaluating manufacturing processes and reviewing deliverables to assist in the development of auto-injector products. This position will support the JPEO-CBD Medical Countermeasures Systems, Chemical Defense Pharmaceuticals (CDP) at Ft. Detrick, MD. The ideal candidate is someone who has demonstrated experience working on programs that moved products through the drug development process. Ideal candidate will have expert level experience with multiple types of auto-injectors.

Candidates must have a current SECRET clearance.

Education and Experience Required
Standard Requirement: Advanced degree in Engineering, Science, Systems Management, Business Management, or a related discipline, as well as ten (10) years of general experience and five (5) years of relevant experience in the medical device and combination product industry. Demonstrated experience providing advice, developing documents, and reviewing deliverables to Integrated Product Teams (IPTs) and/or working groups for development of auto-injector products. In-depth knowledge of combination products, specifically auto-injector manufacturing and development, to include the following: Device development Engineering design and drawings Component development molding processes Cartridge fill/finish and primary container closure systems Working knowledge of Design History Files, inclusive of legacy products being updated to current Good Manufacturing Practice (GMP) standards, as demonstrated in both previous experience and training courses. Familiarity and experience evaluating manufacturing processes using all International Standards Organization (ISO) and American Society for Testing and Materials (ASTM) standards related to combination products (e.g., ISO standards 7886-1, 10993-1, 11608 (all parts), 10993-1, 13485, and 14971; ASTM D4169; etc.). Familiarity with Food and Drug Administration (FDA) guidance for industry (e.g., "Technical Considerations for Pen, Jet, and Related Injectors Intended for Use with Drugs and Biological Products"; Class II devices under 21 Code of Federal Regulations (CFR) 880.5860 and 21 CFR 880.6920; etc.). Experience evaluating feedback and preparing submissions for the FDA review centers involved in the approval of combination products, particularly the Center for Drug Evaluation and Research (CDER) and the Center for Devices and Radiological Health (CDRH). Experience with relevant risk assessment and problem-solving techniques (e.g., Failure Mode Effects Analysis (FMEA), fault trees, root cause analyses, etc.). Be capable of succinctly and clearly articulating plans, proposals, and concerns, both verbally during meetings and in writing via white papers or other documentation, for all products in development. Skills required to be effective in a team environment (e.g., collaborative and persuasive, active listening, etc.). Be capable of self-starting.

Performance Based Tasks Required
Participate in product development teams. Ensure all areas specific to device manufacture are in the right development order and appropriate for the development effort. Review on-going technical efforts to assess appropriateness and identify gaps in the current device design and manufacturing development pathway. In addition, the contractor shall report on appropriateness and gaps in device design and manufacturing. Support FDA submission of auto-injectors. As part of this task, the contractor shall: Evaluate the adequacy of human factors and functional testing to determine the appropriateness of studies (i.e., methodology, conduct, and reporting) Ensure that studies will meet FDA requirements Report on the results found Monitor and report on the standards employed by auto-injector manufacturers and how the standards are employed in the development or production of auto-injectors. Prepare reports to evaluate the use and completion of risk assessment and problem-solving techniques by companies developing auto-injectors. Review and report on Design History Files supporting combination products, including auto-injectors, to assure they are current, robust, and meet all FDA, ASTM, American National Standards Institute (ANSI), and ISO requirements. Provide input and assist in the development of regulatory strategies, target product profiles, and other regulatory documents related to the design, manufacture, and assembly of the device, obtaining input from subject matter experts as needed. Review regulatory strategies related to technical manufacturing for accuracy and consistency. Evaluate Department of Defense (DoD) acquisition documents that include FDA regulatory requirements or impact the drug development timeline. Review and provide written feedback technical records generated during the development process for accuracy and adequacy. Evaluate change control documentation to determine product impact. Evaluate contract proposals specific to the manufacturing development plan. Ensure that protocols, data collection forms, and subsequent study reports are consistent and accurate, and that data support stated results. Conduct on-site visits to ensure that data collected is supported by the raw data. Prepare a report after each visit, to be shared with the entire development team, to convey observations made and how site procedures comply with applicable standards and/or regulations. Evaluate the testing facility, ensuring that its personnel and equipment meet minimum requirements identified within FDA combination product regulations and guidance documents. Maintain interpersonal contacts to increase effective team dynamics; effectively communicating ideas, requirements, and scientific knowledge across and within organizations united for the development of medical countermeasures.
At The Tauri Group, you'll collaborate with an elite, creative team of scientists, engineers, analysts, operations specialists, policy experts, and acquisition support specialists. We attract people who love their work and are dedicated to the complex challenges facing today's world. Our culture fosters engagement and enthusiasm, attracts and retains proven experts, and maintains a flexible environment that supports clients and staff. From our easily accessible offices in Alexandria, Virginia to our comprehensive benefits package, every aspect of our operations is designed to bring us the best in the field.

Financially, The Tauri Group is a smart choice, offering:
Highly competitive salaries 401(k), including competitive matching and 100 % vesting after only one year Business development and referral bonuses
We support your life outside of the office, too, with benefits including:
Highly competitive medical insurance and multiple plans to choose from Dental and vision insurance plans Tuition assistance Professional development opportunities Eight paid hours a year that you can devote to charity Flexible work schedules
Accessibility: If you need an accommodation as part of the employment process please contact Human Resources at HR@taurigroup.com

Equal Opportunity Employer, including disabled and veterans.