Matthew Coonrod Email & Phone Number

Denver, Co, Us

Boulder, Colorado, United States

Broomfield, Colorado, United States

Development Manager at NuVasive responsible for leading Test Engineering and Human Factors Engineering teams within the Surgical Intelligence business unit. Led Test Engineering team to the US and International launch of the Pulse Platform and continue to lead team through Pulse software updates as functionality and compatibility expand, in addition to new development projects. Accountabilities include: - Building, growing, and retaining a high performing test engineering team - Team and project budget estimating and tracking - Management of project scope, timelines, and resources for multiple parallel and competing projects - Leading team through formal verification and validation testing and taking products from development to design transfer - Continuous improvement efforts including Agile methodology implementation for Test Engineering sprint planning, Usability process implementation, JAMA implementation for requirement and test case management/execution, and test automation strategyTest Engineering team responsibilities include: - Collaboration with product owners, marketing, software & hardware development, and systems engineering to determine and lock project scope - Collaboration with systems engineering on technical risk issues and requirement characterization - Formal V&V test plans and testing timeline, including formal documentation required for US and International submissions - Testing that includes reliability testing, usability and human factors (formative and summative), hardware verification (environmental, electrical safety, etc.), software verification (GUI, system performance, and accuracy), and validation of all product user needsPlanning and executing surgeon cadaver labs

Denver, Colorado, United States

Boulder, Co

Project Manager at Plexus responsible for business development, defining and managing project scope, leading a design team, and managing customer budget, timeline and expectations. High level job responsibilities include:o Communicating project progress, changes and status to customers and team members in a timely manner to ensure schedule and customer expectations are met and/or exceeded.o Indirectly manage and coordinate activities of project personnel across geographical boundaries to ensure project progresses on schedule and within budget.o Create and maintain a project plan that outlines the tasks, milestones, dates, status and resource allocation, risk/mitigation plan, communication plan and training plan. Manage project scope, schedule and cost to deliver maximum value.o Facilitate customer and team meetings to ensure schedule, budget and customer expectations are met. Effectively plans project deliverables, goals, and milestones.o Create strategies for risk mitigation and contingency planning. Efficiently identifies and solves project issues.o Manages conflicts within the project team. Performs team assessments, evaluations and actively provides team with feedback.o Strong organizational, time management, presentation and customer service skills.o Ensures that technical and project documentation is created/maintained as necessary.

Boulder, Co

Senior Quality Engineer within Plexus’s Design Assurance group. Working knowledge of regulations/ standards in the design of medical devices, specifically ISO 13485, ISO 9001, ISO 14971, IEC 60601-1 and IEC 61010-1. Experience working through the entire product development lifecycle from concept development to manufacturing transition. Projects include Class I-III medical devices, including implantable and lab diagnostic devices. High level job responsibilities include:o Quality System / Continuous Improvement – High level of understanding of quality system requirements, and the implementation of those requirements into company specific standard operating procedures. Experienced in developing new procedures and maintaining existing procedures as quality system requirements change. o Project Planning – Responsible for the project specific Design and Development Plan and Deliverable Control Plan and holding the project team accountable to these project specific plans, as well as Plexus standard operating procedures, throughout the project duration.o Requirements Development and Verification/ Reliability Testing – Experience developing SMART requirements (specific, measurable, attainable, relevant, timely), developing test plans and test cases, and determining appropriate verification/ reliability testing strategies (sample size, C&R levels, life cycling testing, etc.) to meet customer goals. o Risk Management – Overall responsibility of the Risk Management Plan, Failure Mode Effects Analysis (FMEA), and Fault Tree Analysis (FTA). Experienced in developing risk acceptability criteria, defining occurrence/severity ratings, and developing/ verifying mitigations. o Standard/ Regulations Research and Testing – Proven knowledge of applicable standards to different types of medical devices and ability to conduct accurate and extensive research of unknown standards. Work extensively with third party test houses to certify medical devices to IEC 60601 or IEC 61010.

Temecula, Ca

NPD Quality Engineer @ Abbott VascularQuality Engineer within Abbott Vascular's new product development group directly supporting AV's next generation Bioresorbable Vascular Scaffold (BVS) System, which is the only device of its kind currently approved in the US (as of July 2016). Good knowledge of ISO13485 and other industry standards (CFR, cGLP, cGMP, etc.).Familiar with all quality deliverables (specifics listed below) as they relate to design controls and the quality system as a whole. Responsibilities / Achievements:Design Control Deliverables- Human Factors and Usability Engineering (HFE) File- External Requirements Plan (ERP)- Validation Master Plan (VMP)- Inspection Plan (IP) / Process Monitoring- Design Requirement Rationales (DRR)- Material History Files (MHF)- Test Method Validations- Equipment Validations- Corrective Action Preventative Action (Investigations / Resolution Plan / Effectiveness)Development / Clinical Studies- Test Article Characterization (TAC) / GLP Study- Filing and Aging Study- Sterile Effects StudyProcess Development (PD) Efficiency Projects- Responsible for analyzing / revamping current company procedures that have been found to demonstrate gaps/issues with industry best practices. Projects include an initial analysis of gaps/issues, creating a new procedure, reviewing with stakeholders, implementing and assessing effectiveness across all company sites.Leadership / Mentorship / Education- Summer Intern Mentorship- Real Time Aging Reports- Design Review Presentations

Temecula, California

Divisional Supplier Quality Engineer @ Abbott Vascular- Managed quality plan update, deliverables and integration of 215 suppliers as part of a major corporate acquisition (IDEV SUPERA)- Managed project to ensure accurate vendor to part number linkages of approximately 950 suppliers in SAP- Managed quality agreement updates for 18 critical suppliers to ensure compliance between AV suppliers and Notified/Regulatory Bodies- Took on project to develop dynamic, interactive PDF forms as part of a company-wide initiative- Managed and completed Supplier Change Notifications, Change Orders, Change Requests and Impact Assessments

Greater Atlanta Area

Capstone Project @ Georgia TechWorked with GE, utilizing one of their new technologies, to create a new, innovative product for a different target market. Developed an air-cooled football helmet to combat the effects of heat stroke / over-heating while on the field of play. Responsible for the following:- Design iteration and market research- Completion of CAD models and FEA analysis- Creation of prototypes for modeling and testing purposes- Design of testing apparatus and data acquisition system

Bachelor Of Science (B.S.), Mechanical Engineering

Bachelor Of Science (Bs), Mechanical Engineering

Major: Mechanical Engineering Concentration: Thermal, Fluid and Energy Systems Concentration: Law, Science and Technology