Brett Lane Email & Phone Number

Marlborough, Ma, Us

Marlborough, Ma, Us

Marlborough, Ma, Us

Marlborough, Ma, Us

This position was a contract through TIPS Consulting, Inc.• Wrote protocols and reports for device design verification, regulatory testing, and technical studies• Prepared 510(k) submission material summarizing design verification and regulatory testing results• Assessed impact to risk levels and made quality decisions with supporting justification regarding design changes as well as material selection and processing• Determined compliance of device design, testing, and documentation to internal and ISO standards• Analyzed product specification data using Minitab to assess conformance to statistical acceptance criteria

St. Paul, Minnesota, Us

This position was a contract through Apex Systems, Inc.• Performed installation, operational, and performance qualifications for product manufacturing equipment (IQs, OQs, PQs)• Implemented manufacturing procedure and tooling changes for process-continuous improvement of 6+ product lines across various equipment to reduce operator errors and address non-conformances• Wrote and maintained MPs, IPs, equipment specifications, technical study and validation protocols and reports• Utilized Minitab and Excel for statistical analysis of data• Provided engineering support to product lines by troubleshooting equipment and investigating root causes

My position at American Medical Systems was a contract through Aerotek. • Processed more than 70 adverse complaint events and their medical device reports a week • Complied with FDA, internal, and international standards such as ISO 19218• Communicated with physicians, nurses, representatives, and technical personnel to gain sufficient information for closure of complaint event documentation • Responsible for assessing trends in device failure methods and performance to initiate a corrective and preventative action (CAPA) response if appropriate

Minneapolis And St. Paul, Minnesota, Us

My research focused on myosin-actin activation of smooth muscle contraction by phosphorylation of the regulatory light chain (RLC) in order to better understand the mechanism. Resolving protein structures and their dynamics in the biochemical states of muscle leads to a better understanding of its function and can help direct strategies of molecular-based therapies for macro-scale muscle dysfunction in cardiac and skeletal muscle diseases. I utilized mainly molecular biology techniques such as primer design, site-directed mutagenesis, plasmid DNA-based induced-expression in bacteria, lysis of cells, and extraction column purification of recombinant proteins, as well as gel electrophoresis in preparation of DNA and protein samples for densitometric analysis.

B.Bm.E Biomedical Engineering

Education record