Maren Nelson

Interim Executive Director

2024

Alliance of Angels Life Sciences Screening Committee Co-chair

2018

Alliance of Angels is the largest and most active angel group in the Pacific Northwest. Each year, we invest $10M+ into 20+ companies. Our network of 150+ active angel investors is further augmented by a yearly Fund.

Drug and Device Advisory Committee (DDAC) member

2019

Information about the Drug and Device Advisory Committee (DDAC) can be found at https://www.iths.org/investigators/services/technology-development-center/ddac/

Principal Consultant

2014

M Nelson Consulting is a medical quality systems and product development firm focused on product development process improvement, and creating business value by optimizing required regulatory processes. Recent partnerships include: Glidance, Inc Pearl Antigenics Xonotiv Detect IV Past Partnerships include: Magnolia Medical Harvard Biosciences Biomotum Novuson Surgical EMulate Therapeutics Product Creation Studios (productcreationstudio.com/) Resolution Bioscience Areas of Expertise: Process Improvement • Process Audit • Audit Remediation Quality Systems (FDA 21 CFR 820 • ISO 13485 • ISO 14971 • IEC 62304 • IEC 60601) Project Planning • Regulatory Document Support nolia Medical Technologies, Inc. Harvard BioscienceRisk Management • Use Scenarios • Hazard Analysis

Adjunct Faculty

2014 - 2024

Senior project advisor for the Electrical and Computer Engineering Department.

Chief Operating Officer

2023 - 2024

I'm glad I was able to help Glidance get started on their journey, and also glad they've outgrown a part-time COO! Keep up the great progress!

Screening Committee Co-Chair

2017 - 2019

Review candidate companies to determine technical and business feasibility, and provide information to potential investors. Screening Committee October 2015-March 2017

Sr. Program Director

2010 - 2014

As a Sr. Program Director, I was responsible for initial planning and direction of a replacement product line for AEDs, starting with the identification of stakeholders and the clinical and business needs. For subsequent projects, I worked with internal and external design and manufacturing suppliers to create medical and non-medical accessory products for new global markets. Some of the suppliers were new and I was a member of the audit and selection team. I worked with the marketing team during the project proposal to define the countries for regulatory approval, and to implement new processes for regulatory release after divestiture from Medtronic. The project completion was based on production capability and international distribution. Areas of Expertise: Program Management • Project Management • Project Planning Use Scenarios • Hazard Analysis • Design Risk Management • DFMEA Multi-Site Design Teams • Medical Device Design • Supplier Management Verification Test • Design Assurance • Design Validation Product Manufacturing • Process Risk Management • PFMEA • Process Validation

Sr. Engineering Director

2006 - 2010

As the Engineering Director (2006-2009) and Sr. Engineering Directory (2009-2010), I was responsible for the processes, tools, training, and budget for electrical, embedded software, mechanical, system and project engineers for medical device development and product testing. This included ownership of business and Quality System processes, such as Design Controls. I worked with other system owners to integrate risk management, production support, supplier management, and non-product software validation processes to have well-defined deliverables. I also represented Design Controls during global Quality System audits, including audits for FDA, TUV/ISO 13485, and ANVISA.

Quality System Sr. Director

2009 - 2010

My responsibilities included the overall medical Quality System, Management Review, Document Controls, Internal Audits, and the Quality Assurance team for Physio-Control, a division of Medtronic. I also participated in global compliance audits, FDA audits, and led several corrective action activities for audit responses and FDA Consent Decree remediation. I was a member of a Medtronic task forces that defined new metrics for Quality System compliance measurement, and a member of another task force that rewrote the CAPA procedure to be more consistent across all Medtronic divisions.

Software Functional Manager

2001 - 2006

The software functional manager was responsible for the processes, tools, training, and budget for the embedded software engineers for medical device development and software testing. I worked with other functional managers within R&D to define the design document structure and to improve design review practices. I maintained a project management role as well, and released several product software updates for existing products.

Software Lead Engineer

1995 - 2001

As the software lead engineer on the LP12, I led a team of software engineers that integrated multiple parameters and algorithms (12-lead analysis, SpO2, CO2, NIBP, wireless communication, and power management) into a groundbreaking pre-hospital defibrillator/monitor. The team was responsible for the software architecture, software development, unit testing, and verification testing for the product. The LP12 was a very successful product, and set a new standard for pre-hospital EMS support.

Software Engineer

1991 - 1995

My initial assignments at Physio included the embedded software for therapy delivery for a new defibrillation product, and user interface prototyping for a second new product. I also created software updates and performed code analysis for existing products (LP9, LP10, LP300). As part of remediation activities in 1992, I planned and executed validation for circuit board manufacturing.

Electrical Design Engineer

1982 - 1991

I designed and built development systems to record high-speed radar data from stationary and flight environments. Initially, the systems used discrete components; the later systems used VMEBus card cages and embedded software to stabilize and record data from a helicopter (UH-1B) flight system.