Christie Johnson work email
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Christie Johnson personal email
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Product Safety Risk Management for medical devices doesn't have to be boring or hard. Risk can be simple, impactful, and even (gasp!) fun for early stage medtech entrepreneurs and startups. My friends tell me I have a "sickness" for Risk Management. They're absolutely right.My North Star always points back to Risk. When I collaborate with teams to establish ISO 14971:2019 compliant Risk Management Files (RMF), we implement a set of tools to capture the unique collection of risks for each product. The data is actionable, understandable, and maintainable - even for teams who have never worked in this space.I geek out while coaching teams in risk-based thinking, and in integrating risk control methodologies strategically throughout the product development cycle. We start the RMF early, iterate often, and place it in the center of our thinking as we prioritize safety and efficacy of our patients.
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PartnerProdct Aug 2021 - PresentProdct is a boutique advisory firm founded specifically to support emerging entrepreneurs and early-stage biotech, medical device, diagnostic, and therapeutic companies. Prodct advisors are deeply experienced medical device developers and manufacturers who provide coaching, mentoring, and support for new executives and leaders, especially those unfamiliar with product development and commercialization in highly regulated medical environments.Prodct creates bespoke development, risk management, manufacturing, and quality strategies aligned with 21 CFR part 820, ISO 13485:2016, IEC 62304:2006, and ISO 14971:2019. We underwrite our advice with execution support, including resource augmentation when necessary.
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AdvisorProdct Oct 2020 - Aug 2021
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Vice President Of Quality And RegulatoryMybiometry Apr 2021 - PresentBoston, Ma, UsmyBiometry is focused on one of the biggest healthcare problems in the world, asthma. Our mission is to help asthma patients prevent symptoms and attacks. Our solution combines digital health, patented sensor and device technology, machine learning, and clinical oversight to turn biomarker data into actionable insights. -
FounderKasota Engineering Llc Nov 2016 - PresentIndianapolis, In, UsI help startups and small firms navigate concept-to-launch Product Development and Quality. I create customized, ISO 13485:2016 and 21 CFR Part 820 compliant Quality Management Systems (QMS), remediate QMS-based regulatory notices, and author Design History Files (DHF) and ISO 14971:2019 compliant Risk Management Files (RMF). I often bridge the gap between engineering teams and executive management, helping to translate and communicate requirements to stakeholders. My coaching highlights risk-focused decision making and process implementation wherever possible. -
Product Development EngineerSonablate Corp (Sonacare Medical) Dec 2012 - Mar 2017Charlotte, North Carolina, UsI led the design & development of three single-use kits for therapeutic ultrasound systems from concept origination through product verification, validation, creation of quality procedures, launch, and initial commercial use in the US. I managed multiple major, cross-functional projects requiring 10,000 hours each and a team of 12, including marketing, sales, engineering, quality, manufacturing, and supply chain. I also enjoyed coaching multiple young engineers new to medical devices. Through owning the risk management files compliant with ISO 14971, I kept user/patient safety at the forefront and instilled a patient-centric culture in my team. -
Sustaining EngineerHologic, Inc. Aug 2011 - Dec 2012Marlborough, Ma, UsI led design and product quality for biopsy device ($50 MM annual revenue), including evaluating complaints, all project documentation, redesigning for DFM/cost reduction ($75k annual savings) & product transfer to Costa Rica. I provided technical support to regional sales specialists, clinical education specialists, and manufacturing. Working with the world-class team at Hologic, I learned what it looks like to keep a patient-centric focus throughout development and manufacturing-- and to keep my eyes on Risk Management as a guide in design, process development, and customer feedback. -
Ge Aircraft Engines Design EngineerGe Aviation Jul 2009 - Aug 2011Cincinnati, Oh, UsIn this role at GE, I analyzed the design, manufacturing, test, and integration required to define and support the development of the oil system for the F136 fighter engine used on the Joint Strike Fighter and coordinated multiple component rig tests at once, managing multiple locations, suppliers, and budgets. This role encouraged me to dive deep in my niche area, which led me to understand my strength of having a system-perspective and holistic view of problems. -
Custom Prosthetic Leg Design And FabricationPurdue University Aug 2008 - May 2009I found my love of medical device development in my last project at Purdue University as a senior, designing, fabricating, fitting, a custom prosthetic leg for a 12-year-old with unusual leg geometry. The project was a simple four-bar linkage that extended his residual limb and allowed him to ride a bike for the first time ever. It was all over for me when he flashed the huge smile pedaling on the bike trainer the first day he put on his new leg. I learned some design skills, used a few machines and tools... but this project pulled my heart into the business of helping people and improving quality of life. It took a few years after graduation to get back to medical devices, but this is where the love affair started and I will be forever grateful to him and to Purdue for teaching me to use my skills for good.
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Resident AssistantPurdue University Jan 2008 - May 2009As a Resident Assistant, I had the opportunity to live alongside and serve the women of Windsor Hall at Purdue University. We studied, formed healthy habits, learned about inclusivity, solved crises, talked about poor choices, celebrated good choices, cried, --but mostly laughed together.
Christie Johnson Skills
Christie Johnson Education Details
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Purdue UniversityMechanical Engineering -
Emergency Medical TechnicianCertificate
Frequently Asked Questions about Christie Johnson
What company does Christie Johnson work for?
Christie Johnson works for Prodct
What is Christie Johnson's role at the current company?
Christie Johnson's current role is Partner at Prodct | VP of QA/RA at myBiometry.
What is Christie Johnson's email address?
Christie Johnson's email address is ch****@****ail.com
What schools did Christie Johnson attend?
Christie Johnson attended Purdue University, Emergency Medical Technician.
What are some of Christie Johnson's interests?
Christie Johnson has interest in Resident Assistant, Custom Prosthetic Leg Development, Prosthetics/orthotics Internship, Engineering Student Council, Oxygen Tubing Reel System.
What skills is Christie Johnson known for?
Christie Johnson has skills like Medical Devices, Solidworks, Matlab, Minitab.
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