Thomas Serra, P.E. Email & Phone Number

Lafayette, Colorado, United States

Novare Medical Consulting provides advisory and contracting services for the medical device industry. The company services multiple segments of the industry with expertise and guidance for Product Development, Quality Management, Manufacturing, and Regulatory Compliance.

Lafayette, Colorado, United States

These clients were in the process of merging and had partnered with Novare Medical Consulting to help execute their product lifecycle management process for the combined organization's product portfolio. The planned brands for obsolescence and regional exit were the result of expired legacy product, expiring MDD certification, and overlapping product portfolios. Our team was assigned as the process owners for the completion of this project with assigned cross-functional resources to execute the quality management roles, as required. Responsibilities include:o Collaboration on the creation of the quality plan to define the overall project scope, objectives, timeline, risk assessment, and project team responsibilitieso Creation of the data integrity method using Power Query to identify brand associated itemso Evaluation of the entire PLM and ERP part data for both clientso Determination of Sku level bill of materials and 'where used' application for cross-reference brand strategieso Determination of products needed for revision and removal surgery for all obsoleted brandso Presentation of data results to product managers and finance for scope approval as well as product transition recommendationso Integrated the project forms from SharePoint into the data evaluation modelso Created an automated project tracker and dashboard that was linked to project data on SharePointo Management of all electronic change orders through Agile and Fusion to update lifecycles, revisions, product dispositions, and distribution controlso Evaluation of inventory through COGNOS for determination of reserve allocations and scrap impacto Clean-up of ERP and PLM data for overall alignment between systems and removal of pre-existing obsoleted inventoryo Consulted on the harmonization of the product lifecycle management process between the two QMSo Consulted on additional sustaining activities for SeaSpine related to their preventative maintenance logs and several late CAPAs

Lafayette, Colorado, United States

The client had partnered with Novare Medical Consulting to help establish their quality management system and obtain ISO 13485 certification as well as their first 510k clearance with the FDA. An audit of their existing ISO 90001 quality system documentation was performed to determine the missing requirements. Design controls and a risk management system was implemented to create the design history file for the client's product portfolio.Responsibilities included:o Review of all quality system documents to understand how the client operates within the standards and complies to the regulationo Review of the client's product portfolio to help define user needs and design inputs for design control documentationo Review of client's manufacturing routers to understand workflow and processeso Review of the client's complaint history data from the FDA MAUDE databaseo Review of the coding resources for medical device reporting, Annex A, to align FDA and IMDF codes with customer complaintso Assist the client's team with an assessment of the existing documentation and a determination of the missing documentation needed for the completion of the design history fileo Assist with the search of applicable standards for the intended medical device applicationo Confirmation of the client's complaint occurrence rateso Completion of the hazard analysis report from ISO 24971 with conversion of hazards into failure mode, harm(s), and cause(s)o Creation of failure mode effect analysis tables for application, design, and process risks with determination of current controls and risk control measureso Creation of strength and durability justification memo to address design inputso Creation of device cleanability rationale to address design inputso Creation of environmental and ship test justification to address design inputso Collaboration of input/output trace matrix, remaining V&V documentation, and labelingo Independent reviewer for client's phase review meetings

Lafayette, Colorado, United States

The client had partnered with Novare Medical Consulting for the update of their legacy design history files that were previously approved under the EU Medical Device Directive. This project was completed for the client's flagship pedicle screw system to be compliant under the EU Medical Device Regulation. Legacy design controls and risk management documents were updated to the current company format with the merger of all generative product designs into a single design history file.Responsibilities included:o Merger of all legacy design input/output tables into a single pivot table o Conversion of redundant legacy design inputs and user needs into a single traceability matrixo Creation of a summary report for legacy sterilization testing (reusable products) with confirmation of acceptance criteria for current kit configurations against worst-case test configurationso Creation of a new verification report for reusable instrument cleaning using ISO 17664 and AAMI ST98o Creation of a summary report for legacy user validations to confirm all user needs were validated at prior surgeon labso Collaboration with product development on the summary reports for implant mechanical testing including ASTM F1717, ASTM F1798, and ASTM F543o Collaboration with product development on a new verification document to confirm design outputs on drawingso Collaboration with product development on a new verification document to confirm mating fits between implants, instruments, and system components at MMC/LMC conditionso Collaboration with cross-functional team on update aFMEA, dFMEA, and pFMEAo Collaboration with the manufacturing engineer on the shipping verification summary report to confirm all kit configurations did not present a new worst-case for ISTA 2A testingo Review of labeling verification reports to confirm the IFU, operative technique, and all product labels included the required contento Determination of contact material list for biological evaluation report

Arvada, Colorado, United States

With core competencies in Aerospace, Structural, Mechanical, and Systems Engineering across multiple industries, Cohlmia Engineered Services helps individuals, small, and large businesses find innovative and executable solutions to their toughest problems via elite tier services and products.

Arvada, Colorado, United States

The client had partnered with Cohlmia Engineering Services to redesign and develop their existing mechanical latch system to allow for additional configurations within a single system. This project was accepted under an expedited timeline to align with the predefined production delivery dates for the client's customer.Responsibilities included:o Collaboration in project planning and scheduling with weekly client meetingso Development of critical design review documentationo Collaboration in the trade study for evaluation of design prioritieso Creation of initial design concepts, CAD models, and manufacturing drawingso Determination of loading criteria with review of stress analysis and critical load pathso Design for manufacturing review with determination of inspection criteriao Manufacturing vendor selection with cost analysis for prototyping and production componentso Onsite evaluation of prototypes with design testing and initial assemblyo The final mechanical assembly contained metallic and polymer components using manufacturing methods of CNC machining, and urethane casting

Arvada, Colorado, United States

The client had partnered with Cohlmia Engineering Services to complete a structural analysis report of a preassembled steel railing system. The report required a professional engineering registration seal and was intended to supplement the client's mechanical test data that was obtained from a third-party vendor.Responsibilities included:o Creation of a structural analysis report to determine conformance to IRC 2015 load requirements and IBC 2015 guardrail loadso Completion of stress analysis utilizing an Allowable Stress Design approach with complementary finite element analysis to confirm the requirements of ANSI Pipe Railing System Manualo Creation of free-body diagrams to illustrate the various loads, reactions, torques, and momentso Evaluation of non-concurrent load requirements included infill load, concentrated load, uniform load, and fastener propertieso Factor of safety determined for ultimate strength, yield strength, and design bending stress

Arvada, Colorado, United States

The client had partnered with Cohlmia Engineering Services for the mechanical integration of microcontrollers, antennas, and power modules within a supernova structure kit. Our team was hired to complement the internal electrical engineering team for the completion and delivery of the final customer product.Responsibilities included:o Collaboration in project planning, scheduling, and weekly client meetings to meet delivery timeline and objectiveso Creation of CAD components and final assemblyo Creation of manufacturing drawings and vendor selectiono Design for manufacturing review associated to CNC componentso Creation of installation and assembly documentation with associated bill of materialso On site assembly of electrical and mechanical components for final product

Westminster Colorado

As a result of the work completed within the NPI team and the successful market release of The Tether, Vertebral Body Tethering System, I was promoted to engineering manager. Our team initially included five product development engineers ranging from junior engineer to senior II engineer. Our team owned the surgeon specific instrument program while providing resources for post-market product support and distributed product introductions. My prior experience as a contributing team member to both the surgeon specific instrument program and the post-market engineering team was crucial in managing the daily activities of our group. This role was assigned during COVID which required a hybrid schedule of onsite and remote working conditions for everyone on my team. Additionally, I was assigned the lead role of a CAPA to update the legacy design control process and risk assessment requirements associated to the market release of surgeon specific instruments. This CAPA was completed successfully which redefined the methods and documentation for every request received within the surgeon specific instrument program.Responsibilities included:o Manage team member assignments based on skill set, resources, and project priorityo Oversight of team member compliance to the quality management system, FDA regulatory requirements, and company objectiveso Development of team member skills that aligned to their career path, personal goals, and department needso Responsible for key performance indicator development and reporting to senior leadershipo Responsible for annual budget proposal, team member annual reviews, and product development department interviewero Responsible for all activities of the CAPA to remediate the legacy design control and risk management process for surgeon specific instrumentso Redefined the project management methods used by our team for cross-functional communication and project status tracking through Smartsheeto Managed the UDI updates for EU MDR

Westminster, Colorado

As a result of the work completed on the post-market engineering team and the successful market release of a new product offering for the anchored lateral system, I was promoted to the new product introduction team. My initial responsibilities supported ongoing product development for thoracolumbar systems including a midline approach and a flagship pedicle screw system. Due to the departure of a department colleague, I was assigned the project lead role in a first to market device for adolescent idiopathic scoliosis. The Tether, Vertebral Body Tethering System, was initially released under an investigational device exemption and later approved by the FDA under a humanitarian device exemption. This project required a global project team with cross-functional resources, a best in class surgeon team, and regular engagement with the FDA. Approval of the device required surgeon training and operating room support for access to the system. My role in the project in combination with the surgeon requirements had positioned me as a subject matter expert during the alpha launch of the product. Additionally, I received several patents for the product under US20230310042A1, US20220226023A1, and EP3863543B1.Responsibilities included:o Project planning, budgeting, and Gantt developmento Leader of weekly cross-functional meetings for local and global teamo Monthly reporting to senior leadershipo Primary surgeon engagement for development meetings, validation labs, and surgeon trainingo Design and development of supporting surgical instrumentationo Design and development of surgical sterilization case layoutso Verification testing for implants and instrumentso Validation testing for processes and usabilityo Hazard analysis, risk assessment, risk management report, FMEAo Phase reviews and design transfero Investigational device exemption program developmento Alpha launch protocol developmento Operating room technical supporto Patent think tank participant

Broomfield, Colorado

Zimmer and Biomet merged in 2015 which created a reorganization of the product development department structure and a larger need for post-market engineering support to help sustain the business. My role transitioned to the post-market engineering team to provide additional responsibilities and exposure to the full product portfolio of both companies. My prior work in the surgeon specific instrument program had provided a clear understanding of the structure of design history files and risk management reports. My prior manufacturing experience had provided a strong comprehension of the downstream activities to help resolve supplier issues. This new role focused on legacy production devices and introduction of additional product offering into existing legacy systems.Responsibilities included:o Evaluation of nonconformance reports for products and processes to determine root causeo Review of complaints to confirm FMEA documents correctly captured the failure mode/effect/cause/severity and probabilityo Evaluation of supplier deviation requests and the impact on the final producto Updating legacy design controls based on the resolution of NCRs/Complaints/SDRso Updating production device drawings and CAD models based on design control updateso Providing product development support for corrective actions and preventive actions led by quality engineerso Leading a CAPA for the remediation of the full product portfolio to define the minimum configurations for surgical sets to be deployed when inventory was unavailableo Designing and developing all aspects of a class II implant with supporting instruments, and a sterilization case, to increase the product offering of an existing anchored lateral systemo Working cross-functionally with department leads in marketing, quality, regulatory, manufacturing, and supplier qualityo Managing a diverse workload of post-market engineering projects with introductory expose to the process of new product introduction

Broomfield, Colorado

This role was a career path transition from manufacturing to product development. The responsibilities were focused solely on the design and development of medical devices for the surgeon specific instrument program. The prior M.E. experience had established the comprehension for manufacturing and a fundamental understanding for the process of the program. This role focused on the foundational skills associated with the design and development of medical devices as well as the project management of multiple engineering projects. Responsibilities included:o Designing instruments to meet surgeon specific needs based on predicate medical deviceso Evaluation of legacy design history files with creation of new design controls to meet regulatory and compliance requirementso Creation of CAD models and manufacturing drawings with a strong focus on design for manufacturabilityo Creation of test protocols and reports to address any deviations from existing verification and/or validation documentationo Project management from cradle to grave along with post release evaluation and surgeon feedback engagemento Priority management with surgeon specific instrument requests and manufacturing resources to reduce lead times and improve delivery efficiencyo Manufacturing cost evaluations for new and modified design requestso Cross-functional engagement with quality engineers, regulatory affairs specialists, manufacturing team members, and salesforce representativeso Direct communication and engagement with surgeons

Broomfield, Colorado

This role started at Lanx Inc, an independent spinal fusion company, which was acquired by Biomet in 2013. The responsibilities were focused on internal manufacturing to support R&D prototyping, alpha production, surgeon specific instruments, and the merger of the two companies. The manufacturing environment was a high mix of products with low volume production runs. Additionally, I was one of the patent inventors on US20230157728A1 due to my work with the product development team.Responsibilities included:o Develop device master records, device history records, and pFMEA documents for the manufacturing of class I and class II medical deviceso Analyze manufacturing process flows, procedures, and equipment for improved quality, cost reduction, and reduced lead timeso Develop and maintain quality system documentation pertaining to the manufacturing facility for compliance with ISO 13485 and the FDA 21 CFR 820o Create and execute installation qualification, operation qualification, and performance qualification documentation for manufacturing equipment and processeso Perform design for manufacturing evaluations with CAD and manufacturing drawings to allow for multiple work center manufacturingo Daily cross functional engagement with Design Engineers, Quality Engineers, Manufacturing technicians, and Inspection technicianso Active participant in the integration process for the manufacturing facilities during the Lanx and Biomet mergero Active participant and a primary role during the merger of quality system documentation for the Biomet and Lanx manufacturing departmentso Created value stream maps of the process flow for the surgeon specific instrument program to complete a gap analysis of the Lanx program to the Biomet programo Manufacturing engineer team member for the development of the anchored lateral spine system project (Timberline MPF)o Manufacturing engineer team member for the development of the anchored cervical spine system project (Alta)

Idaho Springs, Colorado, United States

This was a manager and instructor trainer role with primary responsibilities for the department. During the winter, our department had a rotating staff of approximately 40 instructors with ranging ages from 16 to 76 years old. During the summer, I managed four team members that performed general maintenance and operations work in preparation for the following season as well as specialty events. For the winter role, the primary product we promoted was 'people skills' and therefore this role was highly focused on emotional intelligence, leadership, and understanding people's needs. Our purpose was to build trust with our customers through safety, fun, and learning.Responsibilities included:o Learning program developmento Lesson product creationo Department policies and procedures creationo Large group coordinationo Safety trainingo Staff interviewing and onboardingo Weekly payroll managemento Weekly schedulingo Employee and instructor trainingo Employee performance evaluationso Trail buildingo Building maintenance

Evergreen, Colorado, United States

This was a summer internship to provide experience in a technical role:o Field work was completed using the transit tools with data collectors to establish boundaries, define ground reliefs, and confirm construction siteso Office work was completed using AutoCAD to create improvement location certificates, topographical maps, and site plans

Bachelor'S Degree, Mechanical Engineering, 3.69

Activities and Societies: Tau Beta Pi, American Society of Mechanical Engineers, Society of Manufacturing Engineers, Dean's List Honor.

Associate Of Arts (A.A.), Liberal Arts And Sciences/Liberal Studies