- Assisting with writing and executing process validation procedures in accordance with QSR, FDA and international guidelines.- Performing risk assessment activities to identify product quality or compliance risks and leading efforts to mitigate those risks.- Collaborating with engineering and manufacturing functions to ensure quality standards are in place.

Serving as a hands-on Engineer responsible for development or revision of testing protocols and reports aimed at continued regulatory compliance with existing and revised industry standards related to Class I, II and III medical devices.• Led verification and validation projects to address design control and process control gaps to improve internal documentation, manufacturing process output quality, and to prepare for regulatory submissions (primarily EU MDR).• Developed several Design Control Trace Matrices to identify design control gaps and provide an efficient tool for connecting design inputs and outputs to design verification reports and validations.• Developed Master Validation Plans to document and improve internal processes.• Wrote several test protocols and reports with appropriate rationales as applicable, reviewed attribute data, and used Minitab to analyze variable data for test reports.• Supported multiple Q&A technical documentation modules from notified bodies for EU MDR approval.• Remediated inadequate packaging verification testing for several products, which involved ISTA 3A compliant simulated distribution (e.g., study of seal strength and package integrity after pre-conditioning).

(Consultant with ALKU)• Participating in the execution of Quality functions in compliance with FDA QSRs, ISO 13485, ISO 14971, IEC 60601, MDD, EU-MDR, CMDR, CMDCAS and other national and international quality requirements and standards. • Assisting in reviewing and executing design and process verifications and validations, inclusive of IQ/OQ/PQ/V&V protocol and report documentation.• Cross-Functional team member assisting in product design control activities.• Cross-Functional team member assisting in preparation and updates of manufacturing procedure documentation.• Supporting Hazard Analysis, FMEA, FTA or other risk management activities.• Writing new procedures and work instructions or updating the existing documents to drive process improvement.• Evaluating and monitoring manufacturing issues, product concerns, and field complaints to determine opportunities for improving manufacturing and product performance.• Supporting supplier related activities, such as supplier audits, manufacturing validation and/or proposed changes.

(Consultant with ALKU)• Process validation for an injection molded component of various sizes for a hip replacement system.• Wrote protocols and reports• Analyzed data• Supported planning documentation• Coordinated with the project manager regarding the project timeline.• Regularly reviewed work with Spectrum's client for their approval.

(Consultant with ALKU)• Created global reportability guidance documents to determine potential adverse events (PAEs).• Used and scrutinized an array of risk documents such as dFMEAs, pFMEAs, and uFMEAs as well as complaint data to populate the global reportability guidance documents.• Implemented these guidance documents into web app using excel and converting flat files.• Created and troubleshooted the flat files used to fuel the web app based on the new global reportability guidance documents.• Categorized master product families and created groups using risk management files.• Reviewed comments from a medical expert to make alterations to failure mode severities (signaling a potential adverse event).

Consultant with RQM+ (Formerly R&Q)Client: DePuy Synthes Mitek (Johnson & Johnson) - Raynham, MA• Led test projects, designed tests, created test methods, ran tests, compiled/analyzed data, and wrote test reports.• Supported the EU MDR remediation project from the R&D side.• Reviewed DHF reviews of legacy products for remediation and added information as requested.• Worked with SMEs to complete remediation-tasks related to EU MDR.• Assessed product risk as needed (e.g., “Use As Is” for a nonconformance or Reject).• Worked closely with process quality engineers using engineering drawings to brainstorm and analyze possible root causes of recurringproduct failure during shipment.• Investigated product failure of arthroscopic shaver blades through testing to simulate the failure and understand the effects of failure.

• Improved over 20 test methods and datasheets for clarity and to streamline device verification testing.• Executed device verification testing on new designs for cost reduction program.• Verified product performance of 2x-sterilized samples with DV testing, enabling future use of 2x Sterilization, saving over $100,000 of product.• Managed day-to-day testing schedules and followed strict test protocols to meet company standards.• Analyzed raw data from product performance tests and presented results at team meetings.• Reorganized CAD drawings of a product subassembly for easier document access.• Wrote an Engineering Change Order (ECO) and obtained appropriate approval signatures according to workflow protocols.• Performed a re-work on product equipment (the control console) to update the software version.• Worked on several design projects relating to quality improvement, cost reduction, and easier product assembly.• Performed proof of concept tests on prototypes for next generation applications.• Verified new product design performance with DV testing (DVT) of prototype samples for next-generation applications.

Identified manufacturability issues for product design improvements.Designed packaging for new products.Created display stands for product launches.Created work instructions and assembly drawing sets for new products.

- Modeled product parts and tooling components using SolidWorks.- Created engineering prints from SolidWorks models.- Communicated with tooling vendors and negotiated lead times.- Drafted Floor plan for manufacturing equipment using AutoCAD.- Designed alignment system for manufacturing operation.- Tooling Design

> Worked in Prosthetics/Orthotics Dept.> Coordinated with Physical Therapy Dept.- Assembled wheelchairs in the Prosthetics Department.- Fixed up broken wheelchairs.- Reorganized workshop area of spare wheelchair parts.- Assisted with inventory management.- Attended physical therapy clinics.

Worked with UPS drivers delivering packages during the holiday season (2011, 2013).

Created approximately 1.5 miles of hiking trails on Hale’s newly acquired property according to landscape architectural plans.