Mike O'Neill

Mike O'Neill Email and Phone Number

Medical, Biomedical, Healthcare, and Life Sciences Industries @ Dorchester BioMedical
randolph, massachusetts, united states
Mike O'Neill's Location
Randolph, Massachusetts, United States, United States
Mike O'Neill's Contact Details

Mike O'Neill phone numbers

About Mike O'Neill

Purposeful professional with experience in the life sciences, medical, and biomedical device industries, as well as healthcare monitoring. Accomplished in program, alliance, and project management, product development, quality systems, and regulatory submissions. Proven history of leading cross-functional, international teams in the successful development of medical and biomedical devices, combination products, and drugs. Specializations in oncology, neurology, wound healing, and blood disorders. Deep comprehension of AI, digital transformation, and intelligent technology, driving innovation and enhancing operational efficiencies. Skilled in managing the full life cycle of projects, from research to manufacturing, ensuring seamless execution and delivering exceptional results.

Mike O'Neill's Current Company Details
Dorchester BioMedical

Dorchester Biomedical

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Medical, Biomedical, Healthcare, and Life Sciences Industries
randolph, massachusetts, united states
Employees:
2
Mike O'Neill Work Experience Details
  • Ipm
    Senior Life Science Consultant
    Ipm Jun 2017 - Present
    Boston, Massachusetts, United States
    Project & Alliance Management, Life Sciences:o Member of Data Governance and Project Manager for AI-ML drug discoveryo Alliance Manager for an international, billion-dollar drug development project for neurological disorder.o Project Manager for multiple neurological and pain management drug developments using small molecules, and gene therapy. Discovery, Pre-Clinical, IND, Clinical trials (Ph1-3) and regulatory submissions. Cross functional, international teams.o Preparation and review of briefing books, IND submissions, NDA/BLA filingso Project Manager for multiple combination devices for small and large molecules, gene therapy, biosimilars, and “smart” products for clinical and at home use.o Project Manager for corporate wide QMS endeavour to ensure appropriate execution of R&D QMS functions at the affiliate level.o Participated with cross functional team to define the future of data use; by whom, for which purpose, including data cleaning and rules for use.
  • Dorchester Biomedical
    Principal Biomedical & Medical Device Consultant
    Dorchester Biomedical Apr 2009 - Present
    Greater Boston Area
    Research & Product Development:o Designed combination products for wound healing, and drug delivery. Efforts also included preparation and submission of IND.o Partnered on the development and pre-clinical trials for plasma based, tissue sealant and adhesion barrier devices “patch” for human useo Cross functional development, of an anticoagulation PoC device, based on microfluidics and optical array, for a platelet activity determination. Brought this device to the clinic for FIH testing.o Directed the development and regulatory pathway, including IND submission, delivering, the first implantable, passive RFID tag, for tumour marking in breast cancer.o Designing a single lead, EKG, wearable for home monitoring and integration into EHR systemo Developing an advanced healthcare device to address the social-economic divide: “30 million Word Gap”, by translating natural linguistics of family voice(s) using NLPo Collaborated with non-profit group to bring convalescence plasma to randomized clinical trials as well as at risk patients during the initial stages of COVID-19 pandemico Engaged with leading University to design a fully integrated interoperative imaging and guidance system for oncology surgery. Design involves complex datasets and active learningOperations:o Developed end to end supply chain, and manufacturing operations, for multiple start-ups delivering IoT, sensor-based products.
  • Dynasil Corporation Of America (Medical Products)
    General Manager And Director Of Engineering And Operations
    Dynasil Corporation Of America (Medical Products) Jan 2009 - May 2014
    Boston
    • Successfully managed overall operations and finances for medical, biomedical, and healthcare products, ensuring optimal performance and profitability.• Spearheaded the design and execution of pre-clinical and clinical trials for multiple oncology medical devices, resulting in the development of wireless and robotic probes for detecting Sentinel Lymph Node during surgery and generating $30M USD in annual sales.• Led cross-functional teams in the development of biomedical products, including wound sealing, extended platelet storage, and hypothermia design for TBI, resulting in successful product launches.• Delivered a real-time data and imaging system for early triage at the Fukushima Daiichi Nuclear sites, demonstrating exceptional technical expertise and project management skills
  • Ultrasound Detection
    Vice President Of Engineering & Operations
    Ultrasound Detection Jan 2004 - Oct 2009
    Greater Boston Area
    Start-up focused on women’s health care, specifically mammography
  • Innov-X Systems
    Vice President Of Engineering & Operations
    Innov-X Systems 2006 - 2008
    Woburn, Ma
    Start-up that delivered the world's first X-ray tube-based portable XRF analyzer. The company expanded into bench top, standalone, and large metal and contamination systems based on XRF technology.
  • Ammasso
    Vice President Of Engineering & Operations
    Ammasso 2004 - 2006
    Greater Boston Area
    Start-up that developed the industry’s first RDMA-enabled Ethernet sever adapter. Markets included life science, biomedical, informatics, and HPC companies.
  • Alcatel-Lucent Enterprise
    Director Of Engineering And Operations
    Alcatel-Lucent Enterprise 1998 - 2002
    Greater Boston Area
    Start-up that delivered VoIP switch for integration into soft PBXPurchased by Alcatel for $2B
  • Atlantic Aerospace
    Principal Engineer
    Atlantic Aerospace 1994 - 1997
    Waltham, Ma
  • Brooktrout Technology
    Engineer
    Brooktrout Technology 1993 - 1994
    Greater Boston Area
  • Textron Systems
    Senior Engineer
    Textron Systems 1985 - 1992
    Wilmington, Ma

Mike O'Neill Skills

Embedded Systems Product Development Engineering Product Management Electronics Manufacturing Engineering Management Sensors Start Ups Medical Devices Systems Engineering System Architecture Asic Embedded Software Research And Development Semiconductors R&d Distributed Systems Ic Project Management Strategic Planning Operations Management Research Regulatory Affairs Quality Management Technical Leadership Development Projects Cross Functional Team Leadership Surgical Oncology Medical Imaging Pharmaceutical Industry Internet Of Things Technology Management Team Development Supply Chain Management Decision Making Risk Management Team Building Organizational Leadership Mitigation Clinical Trials Product Launch Product Design Team Effectiveness

Mike O'Neill Education Details

Frequently Asked Questions about Mike O'Neill

What company does Mike O'Neill work for?

Mike O'Neill works for Dorchester Biomedical

What is Mike O'Neill's role at the current company?

Mike O'Neill's current role is Medical, Biomedical, Healthcare, and Life Sciences Industries.

What is Mike O'Neill's direct phone number?

Mike O'Neill's direct phone number is +178180*****

What schools did Mike O'Neill attend?

Mike O'Neill attended Salem State University, Wentworth Institute Of Technology, Boston College High School.

What are some of Mike O'Neill's interests?

Mike O'Neill has interest in Children, Health.

What skills is Mike O'Neill known for?

Mike O'Neill has skills like Embedded Systems, Product Development, Engineering, Product Management, Electronics, Manufacturing, Engineering Management, Sensors, Start Ups, Medical Devices, Systems Engineering, System Architecture.

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