Adam Clark Msbme, Pmp Email & Phone Number

Denver, Co, Us

Arvada, Co

Responsible for Cardiopulmonary New Product Development and management of the Blood Lab.

Arvada, Co

Tasked with Special Assignments including Engineering Manager and Site Lead for Sustaining Engineering Mechanics (June 2015 - February 2017). Performed due diligence and freedom to operate analysis on intellectual property in order to advise on business acquisition opportunities. Managed third party GLP testing for 510(k) submission in response to Class II recall and class action lawsuit. Led completion of transfer of acquired product line and associated remediation activities. Audited design controls and optimized manufacturing process for disruptive new product prior to market release. Resurrected project to expand product portfolio and enter into new $9M USD US Market segment.

Denver

Sole engineer on cross-functional team tasked with integrating care for patients with complex conditions and multiple comorbidities. Project aimed to improve clinical outcomes under a cost-effective resource model in light of changes in Medicaid and Medicare reimbursement policies. 180+ hours of clinical immersion in order to conduct process and value stream mapping, clinical staff needs identification, and Kaizen events. Identified and prioritized over 55 areas for task shifting and process improvements, the top five of which created four additional hours of clinical resource capacity per day in dialysis clinics, translating into an opportunity for millions of dollars of additional revenue.

Boulder, Co

Owned development of the processes for release and high-volume manufacturing of a device that will enable comprehensive diagnostics at the point-of-care (POC) from a single patient sample.

Greater Denver Area

Co-inventor of novel technology intended to reduce occlusions and infections in catheters (US 20150011929 A1). Led submission of the Johns Hopkins-Coulter Translational Partnership Grant application which was successfully obtained twice to allow continued development of the technology.

Mentoring and advisement of a team developing a novel fascia closure device to improve safety and clinical outcomes. Co-inventor of this patent-pending device and mentor on business strategy, IP strategy, and design.

Greater Denver Area

Developed a novel medical device that was deemed a “Significant Innovation” by the UN Commission on Life Saving Commodities for Women and Children (US 9,421,036 B2). Development included bench top testing and unprecedented testing in a sheep model. Technical lead on grant submissions and represented the project as a finalist in Round 3 of the Saving Lives at Birth Grand Challenge in Washington D.C. The device is intended for management of postpartum hemorrhage in some of the world's most resource-stricken settings. Through visitation to rural clinics in Tanzania and Bangladesh, I was able to better define the requirements of products to meet the unique conditions in these settings. Worked remotely from an incubator space in Colorado and led the design of the device based of off expert and user feedback, with team members and clinical partners in the US, Bangladesh, and Nepal.

Baltimore, Maryland Area

I had the opportunity and pleasure of advising two undergraduate teams working on projects for improved neonatal resuscitation in developing countries as well as an improved fascia closure device for developed markets. The resuscitation project went on to major successes including People's Choice Award at the Rice360 Beyond Traditional Borders Global Health National Design Competition 2012. The fascia closure project resulted in a patent and many top 3 finishes in business plan competitions across the nation including 1st place at both the University of Maryland & UC Irvine Business Plan Competition(s). Finally, the fascia closure team was named the winners of 1st prize in the 2012 Collegiate Inventors Competition.

Engineering support for research and development teams in Colorado, North Carolina and Japan in development of a new medical device platform for safer handling of hazardous drugs. Investigated manufacturing line issues and instituted corrective actions. Performed installation qualifications of automated UV, solvent dispensing and assembly processes in preparation for verification and validation of the line.

Medical Device Regulatory Compliance and Design Control Consultant for 13 medical device companies.

Disposables Manufacturing Engineer (4/2009-10/2009): Drove continual improvement of the design and production processes for a disposable whole blood processing set sold in volumes exceeding 500,000 per year. Worked to improve product quality, usability, and resource utilization by performing validations, compliance tests, and material research. Participated on a team responsible for ensuring quality of disposable blood processing sets, maintaining a complaint rate less than 0.07%. Responsible for continual process and product improvements, as well as lean manufacturing efforts that resulted in significant cost savings & greater process efficiency. Led training of colleagues in Northern Ireland in streamlined assembly for whole blood processing sets. Production of these sets in Northern Ireland resulted in a 50% capacity increase and a 10% manufacturing cost reduction.Research & Development Engineer (5/2007-4/2009): Developed, validated, and reviewed design requirements for disposable whole blood processing sets. Performed plant tests and assessed results, proposed innovative solutions for issues encountered during development. Managed assembly, sterilization, and delivery of 3,000 disposable sets for 12 clinical and marketing trials. Developed inventive and cost-effective vacuum forming process for custom disposable manufacturing, which greatly reduced cost of product and increased product lifespan and reliability. Managed research and development production schedule, including two full-time resources. Assigned projects and deadlines to meet R&D needs, and initiated control documents for traceability and repeatability.

Research and Development Engineering Intern (5/2006-5/2007): Supported development projects alongside senior engineers including data collection, statistical analysis, investigations, and validations in pursuit of process optimization. Served as a member of a LEAN team focused on lean initiatives and worked with sales and marketing to create simulations of manufacturing processes in order to establish and evaluate production metrics.

Mse In Bioengineering Innovation And Design, Biomedical Engineering

MSE Program at the prestigious Johns Hopkins University Center for Bioengineering Innovation and Design. 400+ hours Clinical Rotations.

Bs, Mechanical Engineering

Activities and Societies: Boettcher Team