Derek Beaupre - Principal
Over 20 years of medical device product development expertise for start-up companies.
• Product Development – comprehensive experience from concept through commercialization for various medical products including capital equipment, reusable, disposable and implantable devices.
• Project Management – lead project teams for product development, mechanical design projects, product verification and clinical validation, and equipment installations including clean room setup.
• Mechanical Engineering/Design – numerous projects using design for manufacturing and assembly including sliding patient treatment table; handheld electromechanical instruments; disposable products including cell sorting cartridge with microfluidics chip, minimally-invasive probes, infusion devices, and sharps containers. Materials selection includes stainless steels, titanium and aluminum alloys, thermoplastics and thermoset polymers, and bioabsorbables.
• Quality Assurance – Failure Modes and Effects Analysis; hazard/safety analysis; reliability engineering; software validation; internal Quality auditing; FDA Master File and 510(k) submissions; writing and implementing a Quality Systems Manual and Standard Operating Procedures for ISO/CE Mark certification and compliance with FDA Quality System Regulations.
• Manufacturing Engineering – transferred multiple product lines from Massachusetts to California; process verification; pilot production and design transfer to manufacturing; cleanroom and manufacturing line setup; fixture and equipment design, installation, and validation.
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