Pete D.

Senior Program Manager @ Cogmedix

About

With fifteen plus years of experience in medical device and consumable product development, design transfer, manufacturing, and sustainment, I am a multi-disciplinary, highly skilled leader who can coordinate cross-functional teams, plan and resource projects, and implement processes in a regulated environment. My mission is to advance and deliver innovative and reliable products to customers that meet their needs and improve their lives. Through my career I have developed a unique set of tactical skills allowing me to excel in driving strategy to action and delivering results. My areas of expertise and key skills include: ✅ Program Management • Project planning, budgeting, resourcing, and monitoring. • Cross-functional team leadership. ✅ Team Building and Engagement • Recruiting, training, and career development support. • Cultivating strong global stakeholder relationships. ✅ Product Development • Design controls, product requirements, and specifications. • Design for manufacturability. ✅ Manufacturing and Sustainment Engineering • Process and test method development, transfer, and validation. • Change control, configuration management, and value engineering. ✅ Operations • Manufacturing site transfer and startup. • Pilot production and planning. ✅ Supply Chain Management • Managing contract manufacturing organizations and vendors. • Strategic sourcing, procurement, supply agreements, and supplier qualification. ✅ Quality and Compliance • Quality management systems, ISO 9001 & 13485, FDA 21 CFR Part 820. • Risk management.

Country

United States

City

Greater Boston

Industry

Biotechnology

Skill

Product Development, Medical Devices, Management, Biotechnology, Design Transfer, Project Management, Cross-functional Team Leadership, Research and Development (R&D), Medical Device R&D, Consumables, Strategic Leadership, Communication, Team Leadership, Team Building, Collaborative Problem Solving, Quality Management Systems, Design Control, Risk Management, Configuration Management, ISO Standards

Experience

Senior Program Manager

Cogmedix

2024-9 - Present · 2 yrs 1 mo

Greater Boston Area

Responsible for managing product development and manufacturing programs for key clients in the medical device field. Owner of stakeholder relationships, team building initiatives, and contributor to strategic business expansion opportunities.

Senior Manager, Design Transfer, LC/MS Reagents & Chemistries

SCIEX

2021-8 - 2023-12 · 2 yrs 5 mos

Greater Boston Area

Led a team responsible for the development, transfer, and sustainment of reagent and consumable products supporting LC/MS applications. Managed a team of up to five direct reports.

Manager, Design Transfer Scientist

SCIEX

2016-7 - 2021-8 · 5 yrs 2 mos

Greater Boston Area

Integral member of a new team responsible for developing and commercializing LC/MS based clinical assays.

Director, Sensor Engineering

Echo Therapeutics

2015-1 - 2016-7 · 1 yr 7 mos

Greater Boston Area

Key leader and member of the senior staff tasked with advancing and commercializing the company's skin preparation and continuous glucose monitoring (CGM) technology.

Consultant, New Medical Devices

Echo Therapeutics

2014-10 - 2014-12 · 3 mos

During a period of reorganization, retained as a key employee to perform research, execute project planning, and explore business development opportunities with the goal of restarting the company and further developing continuous glucose monitoring technologies.

Manager, Process and Test Engineering

Echo Therapeutics

2014-3 - 2014-9 · 7 mos

Greater Boston Area

Accountable for the internal and external tasks related to biosensor development, testing, and manufacturing.

R&D Lab Manager

Echo Therapeutics

2013-4 - 2014-3 · 1 yr

Greater Boston Area

Managed activities in the biosensor development lab including inventory, equipment, and personnel.

Engineer

SpringLeaf Therapeutics

2011-11 - 2013-1 · 1 yr 3 mos

Greater Boston Area

Responsible for developing, optimizing, and manufacturing novel electrochemical actuators used to power a wearable drug administration system.

Postdoctoral Fellow

Berkeley Lab

2010-1 - 2011-10 · 1 yr 10 mos

Berkeley, CA

Postdoctoral research working on new electrolytes and polyelectrolyte membranes for lithium-ion batteries as well as catalysts and membrane-electrode assemblies for energy storage systems.

Research Assistant

Worcester Polytechnic Institute

2004 - 2009 · 5 yrs

Worcester, MA

Ph.D. research studying surface modification techniques to functionalize metals, glass, and polymers for applications including biological sensors, patterning, controllable surface wettability, and photovoltaics.