Lorena F. Aldridge
Engineering Director, Medical devices
Minneapolis, MN · (612) 555 0136 · name@example.com · linkedin.com/in/lorenafaldridge
Key Qualifications
EXPERIENCE
Eighteen years in medical device engineering, seven leading departments
INDUSTRIES
Medical devices, diagnostics, contract product development
SPECIALTIES
Department leadership, program portfolio delivery, design control execution, engineering budget management
SYSTEMS
SolidWorks, Creo, Jira, Windchill, Power BI
CREDENTIALS
Professional Engineer licensed in Minnesota, American Society of Mechanical Engineers
EDUCATION
Master of Science in mechanical engineering, University of Minnesota
Executive Summary
Engineering director running a product development department of sixty four inside a medical device business, reporting to the vice president of operations. Owns the department budget, the staffing plan and the delivery commitments on nine active programs. Eighteen years in the discipline and still the escalation point when a design review stalls.
Signature Achievements
- Delivered nine of ten program milestones on the committed date across a portfolio worth forty two million dollars in development spend.
- Reduced average program cycle time from twenty two months to sixteen by restructuring the design review calendar.
- Cut engineering contractor spend by one point eight million dollars a year while growing permanent headcount by nineteen.
- Closed every engineering action item from two regulatory inspections inside the committed response window.
- Lowered voluntary attrition in the department from seventeen percent to six percent over three years.
- Promoted five engineers into first line management and backfilled each position from inside the department.
- Introduced a weekly resource review that ended the practice of borrowing engineers between programs without a plan.
Professional Experience
Engineering Director
Mississippi Headwaters Medical, Minneapolis, MN 2020 to present
Product development department of sixty four across mechanical, electrical, software and test, reporting to the vice president of operations.
- Run the department budget of twenty six million dollars and the annual staffing and skills plan.
- Own delivery across a portfolio of nine active development programs and their stage gate reviews.
- Manage four engineering managers and set their objectives and performance expectations.
- Hold the department to the design control procedure and prepare it for regulatory inspection.
- Negotiate scope and schedule with marketing and operations when a program slips.
Engineering Manager
Twin Ports Device Engineering, Duluth, MN 2015 to 2020
Mechanical engineering group of twenty two supporting instrument and disposable product lines.
- Managed design engineers through concept, verification and transfer to manufacturing.
- Introduced the requirements management practice used across the site.
- Delivered four product launches, three of them on the original schedule.
- Built the engineering capability plan that justified a new test laboratory.
Senior Design Engineer
Northern Lakes Instrument Company, Saint Paul, MN 2008 to 2015
Instrument design team producing laboratory analyzers for clinical customers.
- Designed fluidic and mechanical subsystems and led their verification testing.
- Acted as technical lead on two development programs.
- Ran the supplier design reviews for injection molded and machined components across the product line.
Licensure and Certification
Professional Engineer, Minnesota Board of Architecture, Engineering, Land Surveying, Landscape Architecture, Geoscience and Interior Design, license number 52418
Member, American Society of Mechanical Engineers
Design controls and risk management training for medical devices
Education
Master of Science in mechanical engineering, University of Minnesota, 2010
Bachelor of Science in mechanical engineering, North Dakota State University, 2008
Core Skills
Department leadership · Program portfolio delivery · Engineering budgeting · Design control execution · Stage gate governance · Manager development · Staffing planning · Cross functional negotiation · Inspection readiness · Retention and hiring