Richard Zernickow Email & Phone Number

S2insight delivers project management training courses, planning Intensive™ sessions, and custom engagements to medical device, pharmaceutical, and life sciences organizations in the United States and internationally.

Plymouth, Minnesota (remote)

• Medical Device Tier 1 supplier developing/manufacturing minimally invasive therapy delivery systems (guidewires, catheters)
• Manage program of interrelated projects for next-generation mitral valve replacement delivery technology, including scope, timeline, risk, and cost management as well as dependencies and priorities between projects
• Lead structural heart therapy delivery catheter projects through DFM, development, and process/equipment IQ/OQ/PQ
• Guide cross-functional teams through risk management/mitigation strategies and root cause analysis tools/techniques

Tualatin / Wilsonville, Oregon

• Develop and control project schedule, product cost, and adherence to quality systems in highly regulated medical industry
• Support site consolidation in relocating and offshoring manufacturing resources producing $50 million revenue annually
• Spearhead site development and implementation of MS project templates across portfolio of new development projects

Portland, Oregon Area

• Develop and manufacture vehicular controls to meet demanding specifications in industrial applications
• Managed project portfolio spanning new product introductions, sustaining (supply chain / regulatory), and cost improvement initiatives at all stages of the development cycle and across manufacturing sites in the USA.
• Supervised 2 direct report project managers and 1 direct report drafting / document support specialist
• Led new opportunity evaluation, review, and approval with management team, including preparing financial analysis and liaising between global sales and local technical teams

San Francisco Bay Area

• Consumer Products company developing and marketing premium skincare products under direction of Dr. Nicholas Perricone
• As the first to bring formal project management discipline to a small company, implemented program management tools and processes which enabled communication and performance of a lean development team and led to.
• Led a global matrix team of 20+ people in delivering $25 million product portfolio of new products to 8 key customers
• Implemented and facilitated project governance, stage-gate development, forecasting, and reporting tools
• Hired and managed a direct report project manager, and coach cross-functional team members

• Led engineering (mechanical, electrical, systems) project teams in design, development, and manufacture of Karma, GoPro’s first aerial drone, including projects for interfacing battery and charging products/accessories.
• Focused on early iteration prototyping and testing to rapidly advance timing required by designing from the ground up
• Managed direct report and external resources (consultants, contract manufacturers) including contract/SOW negotiation

San Mateo, CA

• Implemented in-market product changes for camera and accessory products, including flagship Hero4 camera line
• Established early field failure program using Agile methodology and JIRA software: facilitated root cause analysis, prioritized and resourced change backlog, and managed implementation of product changes
• Identified and executed product cost and supply chain improvements with annual impact in millions of dollars

Mountain View, CA

• Consumer Electronics company developing and marketing cases with designs engineered and tested for device protection
• Led innovation project team in conception, design, and engineering of novel materials and electronics into phone cases
• Directed full concept-to-launch lifecycle of Candyshell Faceplate product line, which became a best-selling product
• On-site oversight of product manufacturing in China, and effective communication across cultures and time zones

Los Angeles, CA

• Led R&D teams in developing and commercializing 8 new consumer products (sunscreens, cleansers)
• Collaborated across marketing, operations, sales, quality, and regulatory functions
• Designed clinical studies in tandem with external clinical sites and authored in-depth scientific documents for claims support and FDA submissions

Los Angeles, CA

• Held roles in Product Development, Clinical Affairs, and Technical Assurance / Quality Engineering
• Authored clinical protocols, product specifications, manufacturing instructions, and SOPs
• Stressed innovation and capitalized on opportunities beyond scope of pipeline projects

St. Louis, MO

• Researched method for accurately localizing electrodes (ECoG) by analyzing brain scan data (pre-op MRI and post-op CT)
• Assisted faculty and graduate researchers in development of brain-machine interface devices and algorithms

Denver, CO

• Developed hardware and software for testing electronic components of continuous-flow blood apheresis machines
• Ensured accurate documentation of technical details of testing platform, devices under test, and software algorithms

Master Of Science (Ms), Biomedical Engineering

• Focus on electrophysiology and bioelectrical systems, including modeling and simulating biopotentials. Coursework and lab experience.

Bachelor Of Science (Bs), Biomedical Engineering