David Feer - Pmp, Mba Email & Phone Number

Princeton, New Jersey, Us

Project Management support of Class II and III devices which are marketed worldwide by the Codman Surgical Specialties & Tissue Technologies divisions. Cross functional project planning of strategic & tactical work to remediate Class II and Class III technical files under EU MDR. Responsible for direction of existing medical device project initiatives using broad experience in planning and execution. Focus upon key product attributes that to establish conformability to ISO 14971 & IEC 62366 as well as internal design controls. Program work in the Neuro or Orthopedics space of life sciences. Cross functional team: 17

Andover, Ma, Us

Responsible for technical project management, Embedded Computer Systems. Classified defense contract work. Cross functional management of scope, schedule, resources, and delivery of multifunctional electronic modules within integrated computer systems. Support of internal & customer sponsored projects for sub-prime clients. Contracting, kickoff, specification, build, test, validation, release and initial production responsibility. 2 projects completed to date. Cross functional teams: 17

Acton, Massachusetts, Us

Technology commercialization. Responsible for the program management, launch alignment of cross functional leaders. Accountable for translating strategic objectives into tactical plans at an execution level. Accountable for evolving business process methods while coordinating diverse project workstreams to meet established budgets, timelines and requirements. Responsible for cross functional roadmap timeline, milestones, integrated schedule and report outs including inputs from R&D, DevOps, Commercial Launch, Label & Packaging, Operations, Cloud & Partnerships. Involved in the technology innovation pipeline to improve product line, the time-to-market, future generation products with adherence to regulatory standards, quality standards and global corporate strategy. Multinational cross-functional teams: 33

Marlborough, Ma, Us

Responsible for all aspects of women’s health program initiatives. Cross-functional authority of scope, schedule and resources in the development of capital equipment and consumable devices to launch in both the Interventional Breast & Surgical and Breast & Skeletal Health franchises. An expert level leader with regulated NPD acumen, QMSs, risk management, traceability, verification, validation, prototype/pilot manufacture, limited market release, launch & post market activities.

Boston, Massachusetts, Us

Director level executive leadership of operations, budget and staff / vendors / suppliers. All aspects of engineering, and program management. P&L responsibility in specification development and production of oral care consumables. Functional lead in specification to production of the 'uPhoria' ultrasonic whitening system that employs sonochemistry (acoustic cavitation) with hydrogen peroxide. Design controls to ISO 13485, 14971, & IEC 60601. Authority over operational expenditures, performance reviews, procurement, and product launch. Release for volume delivery, and deployment to professional dental offices, Nov 2016; Autodesk Inventor modal analysis; SolidWorks CAD.

Responsible for successful business partnerships as a trusted advisor, sponsor advocate, and program architect. Directed the delivery of services to ensure clients' needs are met. Aligned activities, maintained quality, and ensured value of engagement to facilitate a successful, ongoing client relationship. Specific focus on achievable budget, schedule, architecture, performance analysis, risk (technical and program), system integration, and verification activities.

St. Paul, Minnesota, Us

Overall accountability for program scheduling and execution of new product development programs; Contractor; Provide leadership to the team by working to define clear, realistic goals; Identify and help clear barriers to maintain effective and timely progress; Delegate and manage the activities of the functional core team members; Apply the appropriate management techniques given project specific needs, risks and differences in core team member skill levels; Take the lead in the development and maintenance of the project IBP and project planning; Facilitate all core team meetings;

Amsterdam, Noord-Holland, Nl

Program Manager, Medical Consumable and Sensors, 2008 - 2012Owned the development from concept through commercialization of an unprecedented multi-modality medical device sensor compatible with existing Philips IntelliVue monitor system/software. Leadership included meeting product delivery deadlines on budget; followed by program initiation of the 2nd generation infant feeding tube; Ensured that the program was relevant to quality standards and met appropriate CE and FDA standards for medical devices; Complete DHF; Coordinated workflow of the multidisciplinary teams (internal, external, subject experts). Device released for sale.>4 Yr. Budget Est. $5,600,000>VOC research specification>Personnel development >Provided all project plans>Vendor/Supply chain management>Quality Systems / Design Assurance >ISO 13485 / QSR; MDD 93/42/EEC, CFR Title 21 - Part 820, ISO 60601>Product road map, life cycle>Verification/Validation GLPProject Manager (Contractor), Medical Consumable and Sensors, 2005 - 2008Responsible for multiple project teams; focused on 510k approval of pulse oximetry sensors; MRI sensors product line integration, and other key initiatives for the consumables division. Managed multidisciplinary R&D team in the genesis of an unprecedented sensor device for temp, HR, ECG, and respiration. Employed a technical and operational understanding of the electro-mechanical device development, regulatory standards, software artifacts, V&V, and system integration. Responsible for CRO work, PMA assessment, Animal Studies, 3rd party analysis, HW/SW systems performance analysis; Required to communicate technical concepts to diverse stakeholder audience. Projects: Verification of Competitive SpO2 SensorsIntegration of Invivo Clinical Solutions, suppliesDVD+RW MRI memory, Philips Consumer LifestyleNepio MFT device, 11 electrodes, Animal TrialsNepio Temp Only Feeding Tube RequirementsClinical Research, Boston Children’s Hospital NICU

Hampton, New Hampshire, Us

Responsible for the development, specification, and prototype verification of sleep apnea masks for high acuity adult and neonatal patients. OEM Specification development, testing, refinement, V&V, and Pilot Production of a silicone Sleep Apnea Mask device; complete QA specifications to production inventory; Testing criteria, and clinical research; Design engineering, industrial design, production validation; Value Proposition met. Pro Engineer CAD.

A new product development consultancy which provided Systems Engineering, Project Management, Industrial Design and Engineering services to entrepreneurs and multi-national corporations; Sales in 2001: $523K. Services provided to industrial equipment, medical device, and consumer products industries. Tools included SolidWorks, ProEngineer, MS Project; Notable Clients: Boston Scientific: Medical / Speedline: Industrial Equipment / kSaria: Fiber Optics / Bellox Torch: BRONZE IDEA AWARD / Honeywell Consumer Products / Brookstone Home Comfort / Kaz Home Environment. ProE & Solidworks.

Care and Safety Group; Pediatric product concepts developed to be intellectual property;

Directed staff of 5 in industrial design/engineering; health and wellness appliances: Heaters, Air Purifiers, Humidifiers, Fans & Air circulation.

Atlanta, Ga, Us

Master Of Business Administration - Mba, International Business

Bachelor Of Science, Industrial Design