Lise H. Moloney

BS Chemical Engineering

B.S. in Chemical Engineering (summa cum laude)

Medical device professional with extensive expertise in combination devices, clinical advisory board development, technical partnerships, pre-clinical research, and regulatory submissions.

Areas of Expertise

Combination device development and commercialization

Clinical advisory board establishment

Technical collaboration and pre-clinical studies

Regulatory submissions and FDA processes

Antimicrobial technology applications

Quality management systems (ISO 13485)

Education

B.S. in Chemical Engineering (summa cum laude)

University of Connecticut

1997

Professional Experience

Director of Business Development, Healthcare

Sciessent, Wakefield, MA

2011 - 2016

Developed healthcare market strategies for antimicrobial technology; led ISO 13485 quality system implementation

Group Leader – Advanced Research

Covidien Respiratory & Monitoring Solutions

2008 - 2011

Established clinical advisory boards; managed research collaborations; led strategic planning

Senior Research Engineer & Principal Research Engineer

Covidien Patient Care & Safety Products

2003 - 2008

Launched two Class III combination devices; led cross-functional teams; managed FDA design control processes

Awards & Recognition

Design for Six Sigma Black Belt Training (2008)

Covidien R&D Award for Excellence in Product Development (2006)

Covidien Innovation Awards Nominee (2009)

Selected Publications & Patents

Antimicrobial Additives in Medical Devices – Medical Design Technology (2014)

Designing antimicrobial medical devices – Medical Design (2012)

Specifying silver antimicrobials for medical devices – Compounding World (2012)

Need Expert Consultation?

Get in touch with Lise to discuss your case or project requirements.

Schedule a Consultation