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.

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.

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.

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.

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.

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.

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.

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.

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.

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..

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.

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.

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