Mechanical Engineer Project Manager
Resume:
Matthew J. Lazicky
**************@*****.***
Philadelphia, PA 19129
SUMMARY OF QUALIFICATIONS:
Highly skilled Mechanical Engineer with varied experiences supporting medical device industry through every aspect of the product development lifecycle from developing User Needs to validating manufacturing process controls
TRAINING HIGHLIGHTS
COMPUTER SKILLS
Geometric Dimensioning &Tolerancing (GD&T) experience and trained
APQP Certified Professional through Q-1
Trained in Project Management through PMI and Villanova University
Certified in 6 Sigma Green Belt and Lean Management/ Kaizen
Certified in Process Validation per ISO 13485 and 21CFR820
CAPA, Risk Management and FMEA process mitigation experience
-Experienced in Design for Manufacturability and Assembly Principles
CATIA (certified specialist)
SolidWorks (certified specialist)
Minitab (5 years)
MATLAB (9 years)
ANSYS (Static Structural and Fluent) (6 years)
Microsoft Project (7 years)
JIRA Software Essentials (Certified)
-Project Simplification software (DFMA) (1 year)
PROFESSIONAL EXPERIENCE:
Stryker Spine (through Actalent) - Medical Instrument Manufacturer
Project Manager / Advanced Quality Engineer
Shirley, MA (Remote)
April 2022- May 2025
Responsibilities as Project Manager
Managed a multidivisional project, collaborating with a team of 25, to introduce data privacy software updates
Synchronized corporate and local design control procedures to ensure all deliverables meet Stryker standards
Coordinated with task owners to keep deliverables moving through their appropriate workflows to hit milestones
Organized project schedules and met with deliverable owners to ensure project health
Responsibilities as Advanced Quality Engineer
Analyzed current manufacturing procedures for EU MDR 2017/745 conformance
Authored responses to General Safety and Performance Requirements (GSPRs) for EU MDR submittal
Remediated Requirements and User Needs using Systems Engineering Principles
Validated new software installation procedures and antivirus update protocols
Roche (through RQM+) – Medical Instrument Manufacturer
Senior Mechanical Engineer (Project Employee)
Tucson, AZ (Remote)
March 2020 – April 2022
Remediated engineering drawings to introduce GD&T to outdated in accordance of ASME Y14.5-2009
Performed tolerance analysis and fastener assembly checks to ensure manufacturability
Analyzed updated manufacture work instructions through the DFMA principles
NN Inc., Life Sciences – Third-Party Medical Device Manufacturer
Senior Mechanical Engineer
Bridgeport, CT
June 2016 – March 2020
Managed medical device projects for prototype devices and class I and class II production level devices
Validated the transfer of a production line to a new facility after a M&A
Designed CAD model/drawing for multiple product lines, including OEM devices
Authored standard practices in sterile heat seal packaging validation in accordance of ISO 11607
Supported in designing of blister packaging and injection molding tooling for OEM product lines
Fairfield University
Adjunct Professor (Part Time)
Fairfield, CT
August 2018 – March 2020
Curated an ABET-approved syllabus to teach students the fundamentals of modeling and drafting using the CATIA program
Structured lessons around the practice of proper model file management
Trained students toward accomplishing their Certified CATIA V5 Mechanical Design Specialist testing.
EDUCATION:
Master of Science in Mechanical Engineering Fairfield, CT
Fairfield University May 2019
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