Michael Armanini Email & Phone Number

Boston, Ma, Us

Boston, Ma, Us

Cincinnati, Oh, Us

Quality focal for production of T700/CT7 turboprop engine midframes for military and commercial applications. Lead all quality functions for the cell – Quality escapes, CAPA, customer returns, process/product audits etc. Analyze trends in nonconformances daily to determine where corrective action is needed. Driving defect reduction through APPS problem solving and other lean methodologies. Support audits/MRB reviews with DCMA representatives

Billerica, Ma, Us

Production/supplier focused quality engineer for our patient specific knee and hip implants. Managed NCMR program of QMS overseeing investigations, dispositions and tracking reworks to ensure timely closure. As part of 2023 strategic objectives, helped decreased NCMR rate by 20% in MFG and CAD departments in 2023 compared to previous year. Support supplier quality activities such as supplier auditing (ISO 13485 Lead Auditor Certified), supplier qualifying, SCAR management, annual supplier risk assessment etc. Investigated and implemented corrective/preventative actions through CAPA process. Internal auditing of QMS and correction of identified deficiencies. Led a project to bring a new custom OCR machine into our clean room to streamline product verification. Updated inspection plans, work instructions and SOPs to maintain production and improve processes

Assessed non-conformances relating to the manufacture of our laparoscopic surgical tools; executed preventative/corrective actions. Lead engineer on post market feedback including complaint investigations, trending, and reporting. Implemented new incoming inspection software to improve workflow and aid in company goal to go paperless. Head engineer on sterilization, experience with EO/gamma validation and processing. Led effort towards a new self-sterilizing pouch technology. Drafting and review work of instructions, quality plans, FMEAs, specifications, drawings etc. Internal auditing of QMS and internal procedures against ISO 13485, ISO 14971, EU MDR, and 21 CFR Part 820. Led gauge R&R studies on all active gauges to ensure inspection accuracy

Boston, Ma, Us

Design and manufacturing of custom medical devices based on the needs of physicians using CAD, 3D printing and various manufacturing techniques. Aided in the development and implementation of a clinical 3D printing service within our lab to aid surgeons within the hospital. Assisted in a clinical research study involving stroke patient’s suffering from hand function impairments. Using fMRI and a hand grip device built in our lab, the study aims to show the neuroplastic abilities of patient’s brains via rehabilitation.

Boston, Ma, Us

Technician for the Imaging and Biomechanical Testing Core within the Center of Skeletal Research at MGH. Worked closely with a wide range of doctors and scientists throughout the hospital to provide analysis on skeletal tissue of small animal models using micro-computed tomography (micro-CT) technology as well as mechanical testing methods. The core is presented with many different types of projects, as studies range from pharmacological intervention on diseases, genetic manipulations, cancer treatments, etc. As the only member of our research core stationed at MGH full time, I was fully responsible for running the day-to-day activities of the core. Duties include:- Use of micro-CT scanner to image various regions of interest within skeletal tissue- Image analysis to qualitatively and quantitatively describe macro/microarchitecture within the bone using a variety of imaging softwares- Mechanical testing of materials, MATLAB analysis to plot/analyze properties- Statistical analysis on quantitative data- Providing professional reports of our results, some of which may be included in published articles by the research group- Plan and execute novel techniques for analysis for studies which have specific needs specified by the research group- Drafting protocols- Multi-tasking of several projects at one time, all at various stages of analysis- Meet with researchers to discuss project goals and create a plan of action to achieve them. Also discuss the results and interpret our findings at the end of our analysis - Manage core billing

Master Of Science (M.S.), Biomedical/Medical Engineering

Bachelor Of Engineering (Be), Biomedical/Medical Engineering