Lindsay Hardy
@lindsayhardy
Results-driven mechanical engineer with leadership skills
What I'm looking for
As a seasoned mechanical engineer, I leverage my expertise in project management, design, and quality assurance to drive business growth and excellence. With a strong background in mechanical engineering and a proven track record of success, I excel in fast-paced environments, fostering collaborative relationships and driving results.
My experience spans multiple industries, including medical devices, manufacturing, and quality control. I possess a unique blend of technical skills, including proficiency in CAD design, SolidWorks, and statistical process control. I am committed to delivering high-quality results, ensuring compliance with regulatory standards, and driving continuous process improvement.
I am a certified LSS Yellow Belt and hold a Bachelor of Science in Mechanical Engineering from Florida State University. I am passionate about staying up-to-date with industry trends and best practices, with a strong focus on professional development and growth.
Experience
Work history, roles, and key accomplishments
CAD Designer
Apiject Systems Corp.
May 2023 - Apr 2024 (11 months)
Responsible for reverse engineering Blow Fill Seal Machine components, creating 2D technical drawings, and transitioning designs to production. Utilized SolidWorks for 3D modeling and ERP systems for item record creation.
Development Engineer
Actalent Services
Sep 2021 - Sep 2022 (11 months)
Led DHF remediation for compliance with FDA and EU MDR standards. Conducted design control and gap analysis while collaborating with R+D engineering teams to validate documentation.
Quality Engineer
Sunoptic Technologies
Jun 2019 - Jul 2021 (2 years 1 month)
Supported quality assurance for surgical lighting systems, addressing non-conformances through CAPA investigations and root cause analysis. Managed compliance labeling and validated design controls.
CAD/CNC Tech
AG Stone
Feb 2018 - Jan 2019 (11 months)
Prepared engineering drawings and operated CNC machinery to fabricate granite countertops, ensuring precision and quality in production.
Systems Operation & Maintenance Engineer
UF Health
Apr 2010 - Jan 2018 (7 years 9 months)
Maintained high machine uptime for Proton Therapy Systems, performed preventative maintenance, and conducted root cause analysis to ensure compliance with medical standards.
Education
Degrees, certifications, and relevant coursework
Lindsay hasn't added their education
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