Heather Harries Email & Phone Number

Developing a system intended to improve revascularization results after mechanical thrombectomy in subjects with acute ischemic stroke.Building expert Product Development, Quality Assurance and Regulatory Affairs teams to ensure successful product commercialization through efficient program management and streamlined technology design, development, and validation.

Led the initial development of a system intended to improve revascularization results after mechanical thrombectomy.Hired as first RapidPulse employee to build an expert team to ensure successful product commercialization through efficient program management and streamlined technology validation, while maintaining product quality.

Inchinnan, Renfrewshire, Scotland, Gb

Strategically led manufacturing and quality organizations to assure alignment with company's mission and core values. Oversaw Operations, Manufacturing Engineering, Process Development, Business Transformation, Program Management, Facilities, and Quality Systems, Quality Compliance, Quality Operations, and Quality New Product Development teams.• Spearheaded organizational growth required to support patient needs, most recently during COVID-19 global pandemic while ensuring employee safety.• Achieved over 25% growth of operational output in fiscal year 2020 versus 2019, exceeding site's pre-pandemic business commitments while reducing backorders by over 90%. More than 10% operational savings compared to budgeted forecast.• Launched new implantable abdominal aortic aneurysm (AAA) product into United States market during COVID-19 pandemic.• Continued leadership growth, with organization increasing from 31 employees in 2015 to over 400 employees in 2021, while fostering a success-oriented, accountable environment through effective communications, coaching, and development.• Oversaw a $26MM budget while collaboratively developing and executing plans for operational infrastructure of systems, processes, and personnel designed to support company's rapid growth objectives.• Ensured facility maintains worldwide regulatory compliance, with more than 2 years of external quality audits, including multiple Food and Drug Administration (FDA) and Notified Body audits, with zero non-conformances.• Selected as Site Management Representative per ISO 13485:2016, with authority to create, sustain and modify the Quality System.

Inchinnan, Renfrewshire, Scotland, Gb

Expanded and developed the Quality organization from 31 employees to more than 60, including Quality Systems, Quality Compliance, Research & Development Quality, Quality Operations, Receiving Inspection, Final Release, and Documentation Management.• Led plant-wide Quality System administration, ensuring sustained structure in accordance with company's Quality Policy. Site Management Representative per ISO 13485:2016, with authority to create, sustain and modify Quality System.• Oversaw Quality Assurance budget of over $3.5MM and authorizes all quality decisions, including making determinations for remedial action and notifications, product release authorizations, and product quarantine.• Formulated site's first visual quality dashboard and streamlined Management Review process.

Medical device company offering consulting and contracting services to South Florida. Specialties include New Product Development, Quality Assurance, and Program and Project Management.

New Brunswick, Nj, Us

Ensured product quality conformed with established company and regulatory standards while ensuring production commitments were met. Led and developed Quality Assurance and Quality System Engineers, Documentation Department and Quality Operations/Receiving Inspection team. Established and supervised Quality System programs, procedures, and controls for site manufacturing, including leading multisite and virtual teams driving multiple Johnson & Johnson Quality initiatives.• Spearheaded plant-wide Quality System administration, ensuring compliance with company's Quality Policy. Site Management Representative per ISO 13485:2016, with authority to create, sustain and modify Quality System.• Hosted more than 10 external and internal regulatory compliance audits and organized all correspondence and follow up activities, including numerous FDA, Notified Body, and Corporate audits.

Miami Lakes, Fl, Us

Performed compliance audits to applicable government regulations and to company procedures to assure Quality System complies with International Standards, such as 21 CFR Part 820, 21 CFR Part 58, ISO 13485, and ISO 14971.• Communicated compliance deliverables and metric attainment through quarterly Management Reviews for worldwide Cordis Franchise NPD sector and for Cordis West Coast site. Supervised all Quality Compliance activities remotely and developed team members at the Cordis West Coast site.• Improved and maintained the Full Quality and ISO 13485:2003 Certificates across all Cordis sites. Collaborated with British Standards Institute (BSI) to update certificates.• Reviewed all Quality System changes made to Cordis Franchise Documents as compliance expert. Co-led team to improve Cordis Design Control system efficiencies by releasing and training to 39 new procedures executed within 3-month stretch goal requested by upper management.

Framingham, Massachusetts, Us

Planned, coordinated, and directed HeartWare’s Left Ventricular Assist Device (LVAD) programs to ensure continuous development of new products compliant with established worldwide regulatory and quality standards. • Successfully initiated HeartWare’s first commercial profits by coordinating the European CE Mark and subsequent commercial launch. Drove completion of all required design control deliverables to maximize company profits and minimize timelines. • Maintained effective communication through regular updates, including communicating directly with the Chief Executive, Scientific, Financial, and Operations Officers.• Expedited time required to initiate US Investigational Device Exemption (IDE) by effectively coordinating all activities required to complete IDE submission and by interacting closely with Regulatory Affairs and Quality Assurance departments. Led cross-functional teams required to meet all objectives.

Miami Lakes, Fl, Us

Planned, coordinated, and directed QA Carotid and Abdominal Aortic Aneurysm (AAA) programs to ensure continuous development of new products compliant with established worldwide regulatory standards. Managed and developed 6 QA engineers and 1 technician.• Expedited project timelines by simultaneously reviewing and approving design control documentation as both a QA Manager and Engineer while at 67% resource capacity.• Ensured successful product launch through Manufacturing Quality Plan development and implementation; risk assessments, Failure Mode and Effects Analysis (FMEA’s); testing (e.g., concept selection, design characterization, verification, and validation); supplier procurement & qualification; and complaint analysis.• Recognized as a major contributor to streamlining Cordis Franchise Documents using Lean Manufacturing concepts, particularly ones related to design control, making them easier to execute while maintaining compliance.• Accelerated product launch through effective collaboration with NPD, Process Engineering, Production, Regulatory Affairs, Clinical Research, Marketing, and Manufacturing and Supplier Quality Engineering teams.• Minimized regulatory risk by supporting and participating in Food and Drug Administration (FDA), British Standards Institute (BSI), Design History File (DHF), and other internal and external audits.

Miami Lakes, Fl, Us

Organized and led the development of 3 AAA projects and managed test laboratory. Managed 6 direct and 9 indirect reports, including engineers, technicians, and contract support.• Directed successful transfer of prosthesis development and manufacture from acquired Minnesota company to new locations in China, Mexico, and Florida.• Fostered NPD efforts by providing technical expertise and support for all prosthesis-related activities, including new supplier validations.• Assured regulatory compliance by investigating all AAA customer complaints, including root cause analyses, corrective actions, and Kepner-Tregoe analysis.• Demonstrated continuous improvement through the research and closure of 4 AAA Corrective and Preventative Actions.• Established consistency and completeness of DHF’s by pioneering an organizational system eventually utilized throughout Cordis.

Miami Lakes, Fl, Us

Headed the development of self-expanding stent and vena cava filter accessory projects. Administered team responsibilities required for product launch to NPD, Process, and QA engineers and technicians.• Developed and launched worldwide a transhepatic biliary stent delivery system 2 months earlier than scheduled in business plan. Incremental revenue due to early launch was $40,000. Product’s estimated annual gross profit was over $4 million.• Successful product launches through effective cross-functional team management from Concept Phase through Sales Release. Team members were located in Florida, New Jersey, California, Mexico, The Netherlands, and Japan.• Investigated marketplace and customer needs through competitive test studies and through internal and external customer interviews. Subsequently, translated these user requirements into the Product Description’s design inputs.

Miami Lakes, Fl, Us

Oversaw and coordinated the development of new medical device products, including a covered stent and radioactive catheter project. Managed and developed an NPD engineer and 2 technicians.• Augmented successful clinical trials and initial product launch by planning and completing US and Non-US product builds.• Optimized product development cycle by effectively and efficiently designing, developing and validating new products, tooling, production processes, software, and test methods.• Improved marketability of product by minimizing packaging size to allow more products to fit on hospital shelves. Directed all redesign efforts from conception through implementation.• Effectively implemented Cordis’ quality and compliance standards (operation sheets, routers, validations, and tool and product drawings) at vendor site while maintaining supplier's identity and small company perspective.• Improved customer satisfaction with next generation product through animal evaluations with physicians.• Communicated project successes through regular design reviews (both technical and management).

Miami Lakes, Fl, Us

Completed 4-month rotations in 3 areas: NPD, Supervisory and Regulatory Affairs.• Selected as #1 CEP recruit from thousands of college graduates in 1995 and again in 1997.• Expanded Cordis’ product portfolio by designing and developing 4 delivery systems as a NPD engineer.• Streamlined pilot development activities while supervising 15 production operators.• Ensured regulatory compliance by writing a 510(k) and other worldwide submissions and by creating and updating standard operating procedures for the Regulatory Affairs Department.

Contributed to the research, design, and manufacture of several prototype spirometers. Responsibilities included the development and experimentation with prototype instruments, writing computer programs to run simulations, and performing electrical circuit design and construction.

Contributed to the testing of prototype engines and team contributor to the development of FMEA’s.

M.S., Biomaterials Engineering

M.S., Engineering Management

Bs, Biomedical And Mechanical Engineering And Materials Science

High School Degree, General