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Tommy Kronmark personal email
Engineer. Scientist. Tinkerer. Builder. Problem solver. It’s hard to summarize who you are in just a few words. Here is my attempt:I’m an engineer, tinkerer, and builder at heart who champions rapid execution, good data, and data-driven decision making. I’m a master troubleshooter who excels at the intersection of biology, hardware, and software - where complicated systems come together.I'm an up-and-coming people leader with a strong technical background, yet a focus on the people part of leadership. While I love working on medical devices in general, I have a personal interest and passion for diagnostics.Why diagnostics? Because I believe early detection saves lives!Here are some of my practiced skillsets: - R&D, new product development (biochem, mechanical, instrumentation)- Process development, V&V- Algorithm development (FW/SW)- FDA design control & submission pathways- Stability program setup & management - Sampling plans and quality control processes- Project management - CAPAs, NCMRs & other QMS/investigative activities - People managementExperienced in the following areas:- Lateral flow assays (& vertical flow assays)- NAAT assays- Immunoassays- Microfluidics- Electrochemistry- Instrumentation- Algorithms (FW/SW)“Jack of all trades” is a phrase I’ve resonated with a lot, yet have struggled to reconcile the negative connotation it carries...Only after I heard the full phrase did "jack of all trades" begin to feel like a superpower:“A jack of all trades is a master of none, but is still far better than a master of one.”So that's me - a jack of all trades when it comes to medical device engineering.Reach out. Connect. Find out how I can add value to your company or network.(I'm an open networker and would be happy to share my phone/email)---Want to know more?- BBQ enthusiast (Instagram: @tommybbqs)- I'm a Danish-American citizen (2 passports!)- You can find me beaching or hiking in my free time- I love working on my 90's F150 (needs a lot of work)- I'm fluent in English, Spanish, and car culture- Sustainability is very important to me- Renewable energy has always been an interest and hobby (I’ve been brewing biodiesel since age 16)- Add 3D printing to the list of interests and hobbies (I build my own car parts)- Healthcare and helping people have been my passions since lifeguard training
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Co-Founder And CooMuse BioCalifornia, United States -
Process Development EngineerRoche Jul 2024 - PresentSwitzerland 🇨🇭 , ChBringing next-gen sequencing solutions to market as part of Roche Diagnostic Solutions—> Sensor and Cartridge Operations—> Manufacturing Science & Technology- Leveraging my expertise in sensor and cartridge products, consumables, surface chemistry, molecular diagnostics, and IVD industry trends and standards- Operations process development (from conceptualization to characterization, documentation, and deployment), tech transfer, and production scale-up- Bridging the gap between development and large-scale commercial manufacturing of consumable devices for next generation sequencing solutions -
Senior Bioengineer, Technical OperationsCue Health Nov 2022 - Jun 2024San Diego, California, UsIn early 2023, the Tech Ops teams were moved into the New Product Development org. Within this new org, my responsibilities expanded towards R&D, product development, design control, and design change activities.- Led or contributed significantly to new product features and design changes, including:--- Real-time microfluidic buffer flow detection and failsafe/redundancy algorithms--- Microfluidic buffer volume measurement feature to detect and prevent defects--- Piezoelectric transducer subsystem real-time performance monitoring feature--- Dynamic isothermal amplification target temperature algorithm accounting for external inputs--- Operating temperature limit enforcement via firmware algorithms- Created test methods and fixtures by conceptualizing, designing, and building equipment to support the needs of Automation, Operations, or R&D/NPD teams. This was particularly effective for QC/investigation testing of individual input components (rather than expensive full system testing of finished devices).- Determined then set up appropriate sampling plans, acceptance criteria, and QC procedures for functional QC testing of finished devices (very familiar with ANSI ASQ Z1.4 & Z1.9 Quality Standards)- Owned 6 CAPAs, generally managing 2 at a time: 5 against product and 1 against process.- Participated in cohort #6 of Cue Health's Manager Development Program and received the "Rising Star" award for most promising emerging leader.- Continued to manage the Field Failure Analysis team with 2 specialists directly reporting to me. Additionally, became team lead for the Tech Ops Bioengineering team, leading an additional 2 engineers and 2 specialists.- Developed additional expertise around:--- JMP statistics program--- Self-assembled monolayer (SAM) characterization--- Electrochemical signal generation and measurement--- qPCR, ddPCR, and isothermal amp plate assays--- Lyophilized reagent formulation optimization--- Change management and design control -
Bioengineer Ii, Technical OperationsCue Health Feb 2022 - Nov 2022San Diego, California, UsContinued in the Tech Ops department, but my duties expanded towards cross-functional project management of sustaining engineering activities for on-market products:- Contributed significantly to the shelf-life extension project / product stability program by assisting in study design, resource planning and management, data analysis and report writing. Success with the stability program was a key contributor to our first De Novo approval from the FDA (the first ever FDA approval for an over-the-counter molecular diagnostic test for at home use).- Advanced company-wide understanding of our flagship cartridge product through conception, planning, and execution of engineering studies characterizing critical-to-quality (CTQ) design variables. The technical summaries I wrote became foundational information for our New Product Development engineers developing the company's next-gen cartridge design.- Further developed the Field Failure Analysis team, bringing on and managing two Tech Ops Specialists to run customer complaint intake, product investigations, and efficient product issue resolution.- Developing the Field Failure Analysis team freed my time to implement more efficient systems and automation in the their investigation and root cause feedback processes, decreasing customer complaint resolution time by greater than 50%, improving issue identification and feedback speed, and ultimately contributing to a reduction in field failure rates by ~65%.- Worked closely with our Quality department as the lead investigator for 3 product CAPAs. As lead investigator, I drove root causes identification experiments, then designed, developed, and implemented solutions, and completed effectiveness reviews with a 100% passing rate.- Above CAPAs gave me in-depth experience with control sample materials, LoD/LoB testing, microfluidic flow performance and consistency activities, and PCR/isothermal plate assays.
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Bioengineer, Technical OperationsCue Health Jul 2021 - Feb 2022San Diego, California, UsAs an engineer in the Technical Operations department, I often described this job as an "Operations Firefighter." Operations has fires. I'm called to put them out. Here's an example of what that looked like:- Set up an in-process testing (IPT) system for production quality monitoring allowing for rapid response to developing product quality issues. Fast resolution allowed lines to continue producing good parts, improving yields (80% to 95%) and saving dozens of batches and $1,000,000s during Cue Health's high volume manufacturing (HVM) ramp up.- Led NCMR investigations for failed product to identify the quality problem's root cause, then worked cross-functionally to develop and implement solutions to help prevent future lot failures (e.g. FW algorithms, consumable part spec revisions, automation process optimization). Each batch failure that was prevented saved ~$100,000.- Utilized data analysis skills to create systems that would help identify performance trends and good/bad portions of a batch. The system allowed for culling of bad regions from a failed batch and salvaging then releasing the good portions, saving the company $10,000s each time.- Supported the completion of a $481M contract with the DoD to grow from 2 active manufacturing lines to 14 lines and to a production capacity of 1M tests per week (final yield). Total quantity of devices provided to the DoD exceeded 6M+.- Established then managed the Field Failure Analysis team and process, which provided technical expertise for complaint handling and post-market surveillance. The team and field failure monitoring contributed significantly to issue identification and product improvements.- Field emergency response and hotfix story: identified an emerging product issue in the field, then developed, tested and pushed a firmware (FW) algorithm hotfix, resolving the product quality issue and improving customer experience, all within 1 week and within FDA design control (talk about a crazy week!)
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Graduate Research AssistantHp Jan 2020 - Jun 2021Palo Alto, Ca, UsHP sponsored research grant through Cal Poly BMED (reporting to HP management)- Lateral flow assay (LFA) signal optimization, loss reduction, and improved limit of detection- Application of Eriksson et al. Geometric Flow Control Lateral Flow Immunoassay Devices (GFC-LFIDs)- Immunoassay platform design and development for disease detection and diagnostics- Immunoassay reagents and materials selection and purchasing- COMSOL computational fluid dynamics (CFD), transport modeling, and kinetics modeling- MATLAB modeling for rapid design of experiments (DOE) screening- Experimental design and validation of model; model accurately simulates next-gen LFAs- Test method design and validation for fluid flow, reagent compatibility, signal quantification -
College Of Engineering - Teaching AssistantCalifornia Polytechnic State University-San Luis Obispo Dec 2019 - Mar 2021San Luis Obispo, Ca, UsWhat's better than helping other people learn? I'll tell you: helping other people learn AND personally gaining better familiarity with tough topics. What topics? See below.• BMED 425 - Biomedical Transport Phenomena• BMED 430 - Modeling and Simulation• BMED 520 - Modeling of Biomedical Systems• EE 450 - Solar Photovoltaic System Engineering• EE 434 - Automotive Engineering for a Sustainable Future -
Assay And Reagent Development InternVentana Medical Systems Jun 2019 - Sep 2019Tucson, Arizona, UsFirst introduction to the biotech industry: I capitalized on the experience. By the end of the summer, I was well-versed in diagnostics methods & tech, design control, FDA regulation of class II devices, and much more! As a cross-functional intern with the Assay and Reagent Development and Early R&D departments, my contributions included:- Document control, GDP, and audit preparation in an FDA regulated environment- Optimization of a novel nucleic acid capture method for tissue screening- Reduction of non-specific binding events during nucleic acid capture- Improvement of signal detection via careful nucleic acid handling and amplification- Liquid handling for DNA amplification and processing- Testing of new thermal treatment process of tissue samples on automatic diagnostic platforms -
PresidentCal Poly Future Fuels Club Jul 2017 - Jun 2019Built up the best damn engineering club on campus. What's more? The experiences we curated through this organization inspired dozens of students to pursue meaningful careers in engineering, myself included.- Managed club projects and events, allocated resources, maintained member enthusiasm and activity, served as a role model, trained officers, and facilitated effective meetings- Contributed significantly to the growth of the organization, including recruiting and retaining 30 new members (400% increase) and acquiring a $3000 budget increase (700% increase) from donations, fundraising, and sponsorships- Planned, coordinated, and oversaw the 2019 Central Coast Sustainability Festival: an expo featuring student projects, student clubs, workshops, and a lineup of live musical acts -
Undergraduate Research AssistantU.S. Doe Research Center For Biofuels And Water Recycling Jan 2018 - Jul 2018- Performed hydrolyzation of carbohydrates on algae strains and analyzed resulting monosaccharides to determine percent carbohydrate composition of samples- Aided biochemical analysis team by analyzing lipid content of algae strains with gas chromatography- Assisted in data collection for the selection and development of algae cell lines with promising characteristics for production of biofuels (ethanol, biodiesel, and biocrude)- Tested for nutrient limitation in algae samples cultured in recycled wastewater and hydrothermal liquefaction byproduct using spectrophotometry- Well versed in lab safety, quality control and quality assurance techniques
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Pathology Department ClerkSjællands Universitetshospital Jul 2017 - Nov 2017Roskilde Og Køge, Region Sjælland, DkAs an entry level lab technician in the hospital's pathology lab, I routinely did the following:- Supported the development and optimization of hazardous waste management.- Assisted lab staff in routine methods by gathering and recording data.- Observed and assisted in autopsy operations, tissue sampling, and sample preparation.- Responsible for verifying that samples were safely handled, delivered, and filed. -
Head LifeguardSaint Helena Unified School District Dec 2015 - Sep 2016As a head lifeguard with SHUSD, I was responsible for opening and closing the property as well as performing routine maintenance on the facility and maintaining water quality. Apart from daily duties, I was responsible for:- Managing public concerns by explaining, clarifying, and demonstrating established polices.- Assisting in training new employees on effective lifesaving techniques.- Showing proficiency under pressure by reacting calmly and quickly to emergencies.- Cleaning, repairing, and maintaining an effective facility. -
LifeguardWaves Aquatics May 2015 - Dec 2015- Implemented knowledge of effective teaching techniques and practices- Facilitated a wide variety of calls involving disorderly conduct, theft and similar activities- Recognized as a valued worker, always punctual and providing help before being asked
Tommy Kronmark Education Details
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California Polytechnic State University-San Luis ObispoBioengineering And Biomedical Engineering -
California Polytechnic State University-San Luis ObispoBioengineering And Biomedical Engineering
Frequently Asked Questions about Tommy Kronmark
What company does Tommy Kronmark work for?
Tommy Kronmark works for Muse Bio
What is Tommy Kronmark's role at the current company?
Tommy Kronmark's current role is Co-Founder and COO.
What is Tommy Kronmark's email address?
Tommy Kronmark's email address is tomas@cue.me
What schools did Tommy Kronmark attend?
Tommy Kronmark attended California Polytechnic State University-San Luis Obispo, California Polytechnic State University-San Luis Obispo.
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