ERI - Key Persons
Job Titles:
- Director of Product Development
Jeremy brings a breadth of experience from his 16 year career leading technical efforts to his current role as Director of Product Development at ERI group. Jeremy focuses on project execution, ensuring that ERI Group seamlessly integrates product development excellence with robust program management to consistently exceed clients' expectations.
Jeremy has been with ERI Group for 10 years, working as an engineer, program manager, engineering manager, and director, overseeing many aspects of ERI Group's core business. Jeremy has led product development, manufacturing operations, IT, and program management throughout his time at ERI.
John has established himself as a leader in the overall integration and execution of regulatory affairs & quality management systems in the medical device design, development and manufacturing continuum. During his 30 years of experience in the medical device field, he has successfully implemented regulatory approvals for various class devices in both the USA and EU, he has successfully mitigated recall and market withdrawal situations for large and small companies. He has designed and implemented Quality Management Systems (QMS) for all classes of devices, compliant to USA, EU, Canadian and other global regulations. In addition, he has successfully remediated systems and records for companies under rigorous regulatory oversight. John is adept at providing practical solutions in compliance with the FDA Quality System Regulation (QSR), ISO13485:2016, ISO 9001:2015, ISO14971, ISO10993, 60601-1, 62304, ISO 14155, 62366-1, HE-75 and a broad range of other technology, device specific standards and regulatory standards including design controls, process validation and statistical analyses. John is widely recognized for presentations and leadership in his field.
Job Titles:
- Associate Director of Manufacturing
- Leader in Medical Manufacturing
Kevin is a leader in Medical Manufacturing, Supply Chain Management and Product Development. With over 20 years of experience in the medical device industry Kevin is proficient in all operational aspects of manufacturing; procurement, material management, warehousing and logistics, contracting and implementation of multi-million-dollar projects.
He has a demonstrated a track record with domestic and global integration, and creation of Supply Chain organizations for international businesses in medical device product development. Kevin is a profit-oriented manager with a passion for challenges and a commitment to enhancing cost effectiveness throughout the manufacturing and operations process.
Kevin has a B.A. degree in Political Science/Pre-Law from the University of Denver.
Job Titles:
- Founder of LINK Product Development
- VP of Product Development
Marc brings over 25 yrs of product development consulting expertise with a background in mechanical engineering, program management, and industrial design. A proven and respected leader, his experience spans a wide range of development projects, from medical devices to consumer products and industrial solutions.
Marc is also the founder of LINK Product Development, an award winning product design firm in Denver, Colorado focusing on industrial design, marketability, human factors engineering, and prototyping. LINK was acquired by ERI Group in July of 2022, and continues to represent both our medical and non-medical device clients. Marc is a proponent of local manufacturing and community outreach into Colorado's design and engineering schools to promote STEM learning and the discipline of good product design. He actively guest lectures and teaches as an adjunct professor at many of the universities in the Denver area.
Tasha is a proven leader in medical device program delivery, with over 20 years' experience integrating technical and commercial teams. Tasha provides enterprise leadership for ERI Group, ensuring that the team at ERI Group can successfully deliver on partnerships with clients.
Tasha has focused on enabling small, often venture-funded, medical device companies to proceed to commercialization efficiently and effectively. Her experience spans New Product Development and Commercialization, Risk-Based development strategies, and implementation of least-burdensome approached to accelerate development lifecycles across a variety of medical devices including Vascular, Venous, Respiratory, Gynecological, Analytical testing and diagnosis, Drug Delivery, Wearables. She also has deep experience in Regulatory Strategy & submissions, including PMA, 510(k), EC Tech File, Canada, Japan, FDA pre-submission and communication management including multiple successful Breakthrough Device Designations.
Prior to ERI, Tasha has held various leadership positions in start-ups, with multiple successful exits to J&J, Abbott etc., most recently holding COO position at Sana Health, a novel wearable for pain and mental health management. Tasha has considerable depth of engineering and regulatory consulting experience, across 5 organizations, including Vention, who exited to Nordson in 2018 after sustained double-digit growth under her leadership. Tasha is a Chartered Mechanical Engineer and PMP.