Senior Manager, Global Technical Sourcing & Contract Manufacturing

• Sep 2023 - Present

Technical Sourcing Manager, Global Contract Manufacturing

• Feb 2022 - Sep 2023

Responsible for global technical product transfers to new or existing partners, manufacturing improvements, relationship management, supply chain continuity, and unit cost improvement

Sustaining Engineering Manager

• Nov 2019 - Feb 2022

Managed process engineers in continuous improvement, cost savings, production development, and product line manufacturing support roles. I set departmental goals to achieve the company's strategic plan with a focus on project organization and prioritization across product lines and departments.

Process Engineer III

• Jun 2018 - Nov 2019

-Managed current and potential suppliers for cost savings and quality improvement opportunities-Engineering and Operations liaison for product manufacturing location transfer-Wrote and performed sustaining engineering feasibility, development, and verification protocols and reports-Initiated process improvement projects to improve efficiency of current manufacturing processes and reduce costs-Auditor for current and potential suppliers-Compiled and analyzed data to set action and control limits for new processes-Provided technical support for Tissue Processing Laboratory and medical device product lines-Assisted with implementation of new processes and equipment related to new product launches -Managed engineering change order and presented to Engineering Change Committee Show less

Engineer II

• Jul 2016 - Jun 2018

-Led supplier change, new product development, and yield improvement projects to increase company profit-Project manager and lead engineer for creation of new product Design History Files (DHFs) with 510(k) submissions-Lead profitability projects with projected global annual savings of over $800,000-Complete all design control documentation such as new risk management file creation and design inputs/outputs-Audit new and current domestic and international suppliers and manage additions to approved supplier list-Evaluate potential projects using ROI, IRR, NPV, and payback period calculations-Lead design reviews and communicate team objectives, milestones, and progress of current projects-Identify and quantify cost savings opportunities and propose feasible projects to management-Manage current and potential suppliers for cost savings and quality improvement opportunities-Create CAD models, perform feasibility, design verification, validation, and design validation testing on new designs-Coordinate with mold suppliers and automation companies to create innovative in-mold assembly processes-Create and update project schedules based on changes in time, resources, and costs -Plan and perform usability studies with clinical staff including blood and animal testing-Track and report monthly savings of completed projects-Write and execute technical reports for acceptance criteria of supplier changes or new products-Monitor current inventory levels with implementation of new products to follow supply chain trends-Complete compliance related activities as requested Show less

Production Supervisor

• Feb 2016 - Jul 2016

-Supervised second shift associates in blood monitoring product lines-Interviewed, trained, and approved associate competencies on various manufacturing processes-Updated and tracked waste in various steps of the manufacturing process to evaluate high fallouts and bottlenecks-Planned associates’ training schedules and rotations by organizing cross training to increase skill sets-Arranged associates based on efficiency rates and subassembly inventory levels to maximize product output-Wrote Nonconformance Reports, enforced quality bulletins, and updated deviations in production area-Identified root cause and implemented corrections for Nonconformance Reports-Managed associate timecards, wrote corrective action reports and discussed disciplinary actions with associates-Completed, investigated, and executed associate incident reports for associate’s safety-Isolated, segregated, and quarantined affected product during machine malfunctions-Updated production procedures to clarify process instructions and checksheets to document inspection criteria-Reviewed Device History Reports and yield reports for each lot of product Show less

Engineer I

• Jan 2014 - Feb 2016

-Project lead of transferring products to in-house manufacturing production from third party supplier-Engineering representative in Off Pump Coronary Artery Bypass technology acquisition and product design transfer-Created multiple DHFs, Risk Analyses, Design Validations, Test Method Validations, and Operational Qualifications-Created and evaluated surveys sent to surgeons on usability of product line-Coordinated with third party suppliers on translations, IFUs, raw material specifications, and quality issues-Created new production and quality procedures and checksheets for new manufacturing processes-Trained quality, engineering, and incoming associates on new inspection methods-Completed ISO 11607 packaging validation testing for new packaging configurations-Aided in creation of new part numbers with new and modified BOMs, item maintenance, and routing documents-Completed investigation of Supplier NCR-Supported management in FDA and BSI audits-Completed and tracked projects with total annual savings of $660,000 Show less

Temporary Process Engineer

• Jun 2013 - Dec 2013

-Assisted completing DOE and Gauge R&R studies for dilator tip forming machine replacement project -Performed testing and measuring products using Instron and Vision Measuring System -Drafted layout of New Engineering Laboratory -Assisted completing DOE and Gauge R&R studies for dilator tip forming machine replacement project -Performed testing and measuring products using Instron and Vision Measuring System -Drafted layout of New Engineering Laboratory

Intern

• Jun 2013 - Jun 2013

Internship on patient intake, device fabrication and modification, patient care observation and documentation. Internship on patient intake, device fabrication and modification, patient care observation and documentation.