Fernando Rea Email & Phone Number

Florida, United States

Kalamazoo, Mi, Us

Digital, Robotics and Enabling Technologies (DRE)

Kalamazoo, Mi, Us

Divisional Process Owner (DPO) for Design Controls at Joint Replacement Robotics (JRR)

Kalamazoo, Mi, Us

Raritan, Nj, Us

Supporting New Product Introduction (NPI) and Life Cycle Management (LCM) of Biosurgery Products – Laparoscopic Portfolio Serving as a project team technical lead in all matters related to Quality Engineering Responsibilities include the following: Leading technical team to overcome challenges in design and process Developing quality strategies and validation plans for products and processes Authoring, reviewing and approving protocols and reports Participating in technical design reviews as part of Design Control activities Partnering with external suppliers as main point of contact for Quality support Supporting Quality efforts to achieve post-launch stabilization goals and objectives Maintaining compliance with FDA 21 CFR Part 820 Quality System Regulation (QSR) Examples of key deliverable support include: Component QualificationsFinished Goods SpecificationsProcess and Test Method ValidationsWork InstructionsRisk Management (pFMEA)Technical Studies (Biocompatibility, Endotoxin, Sterilization, Stability, Packaging/Transit etc.)

Somerset, Nj, Us

Served as owner of product quality in Medical Processing (MP) manufacturing and inspections of implantable endoscopic ligation clips Responsibilities included the following: Routine monitoring and improving of existing processes to increase production yields and reduce scrap using statistical process control (SPC) and engineering evaluation Quarantining potentially nonconforming product/material and performing required investigations via material review board (MRB) Establishing and executing the following requirements to fulfill supplier process change requests (SPCR) with medical device customers:Process ValidationsEquipment QualificationsRisk AssessmentsCapability AnalysesEquivalency StudiesVisual/Dimensional/Functional Testing/Inspections Coordinating/executing action items for corrective actions to address nonconformances Regularly meeting with customers to discuss and manage project progress

Gothenburg, Se

Served as Test Method Validation Subject Matter Expert (SME) Addressed gap assessment findings for Cardiac Surgery medical devices Responsibilities included the following: Owning CAPAs and Failure Investigation Reports (FIR) Implementing changes/improvements to existing products as a part of Design Controls Risk management – Revising FMEAs (Design, Process and Clinical) as needed Investigating Product/Process gaps with respect to Validation/Verification Conducting Process Characterizations and Feasibility Studies for Process Improvement Authoring and executing protocols to generate final reports for closure Investigating, resolving and documenting deviations with robust rationale

Munich, De

Managed Project Plan for Receiving Inspection Acceptance Activities under the Quality Transformation Program (QTP) to improve batch-managed system for SAP integration Created, classified and assigned inspection plans to parts based on function and risk Refined and validated production test methods for inspecting manufactured parts

Warsaw, Indiana, Us

Development & processing of hip products under the Revision Team strictly for Design History File (DHF) RemediationReviewed and completed the following design assurance documentation for existing orthopedic instruments, Class II and Class III medical devices: Design Control Traceability Matrices (DCTM)Design Change History LogRisk Management ConfirmationStock Keeping Unit (SKU) Attribute Data ReportIdentified and closed product development gaps, which required further investigation and/or testing as part of design review

New Brunswick, Nj, Us

Supported remediation of Neurovascular Intervention Class III medical devices Developed and executed the following items for remediation and production support: Installation Qualification (IQ)Operational Qualification (OQ)Performance Qualification (PQ)Process VerificationTest Method Validation (TMV)Gage R&R (Repeatability & Reproducibility)Technical/Feasibility ReportsWorked closely with multiple departments (Manufacturing, Quality, Operations, R&D, Product Development etc.) to improving existing processesAuthored and improved manufacturing documents (work instructions, visual standards, etc.) Investigated and closed non-conformances (NCs) via engineering evaluation, equipment calibration, preventive maintenance, critical system changes, and operator training/certificationParticipated in Design Reviews with department functional representatives Contributed to new product development for next generation of Envoy DA Guiding CatheterSupported the facility for the following internal and external audits: Quality Systems, Microbiology & Sterilization, and FDA review of Quality Systems

Baptist Hospital of Miami, Emergency DepartmentProvided real-time documentation of the following items using Electronic Medical Record (EMR):Patient medical historyCurrent symptomsAdmission diagnosisDischarge impressionTreatment progress including test results, notes, reports etc.Demonstrated ability to maintain patient confidentiality and privacy in accordance with governing HIPAA regulations

Miami, Fl, Us

Concentration: Analysis of the Effects of Static Magnetic Fields on the Proliferation of Osteoblasts and Osteoclasts

Miami, Fl, Us

Lectured physics concepts and principles to FIU studentsPerformed simulations and experimental demonstrationsDeveloped and implemented new teaching methodsParticipated in continuing physics education seminars

Miami, Fl, Us

Tutored students in the following subjects and respective laboratory courses:College AlgebraTrigonometryCalculusBusiness CalculusMultivariable CalculusDifferential EquationsPhysics with CalculusPhysics without CalculusGeneral ChemistryWriting & Rhetoric