Full-Time
Process Engineer
Posted on 7/21/2025
ByHeart
51-200 employees
Produces infant formula with grass-fed milk
No salary listed
Reading, PA, USA
In Person
 Process Engineering |
|---|
- Bachelor’s degree in a related field or a minimum 5-7 years proven continuous improvement analytical experience from a similar role, including project management and business analysis
- Dry spraying experience required, preferably in food processing or dairy industries
- Support production in identifying, verifying, analyzing, and implementing process improvement and process re-engineering opportunities.
- Provide technical and analytical support for process improvement initiatives.
- Develop process analysis and re-engineering to improve efficiency, lower costs, and improve product quality.
- Perform project management, analytics, and measure to ensure milestones are met and deliverables achieved.
- Identify and manage resources to deliver effective solutions.
- Establish norms and standards of production.
- Infant Formula manufacturing experience (plus)
ByHeart produces and sells infant formula in the United States using a patented protein blend derived from organic, grass-fed whole milk. Its formula is designed to resemble breast milk and has clinical evidence of benefits such as easier digestion, less spit-up, better nutrient absorption, and improved weight gain, plus support for brain and eye development, immune health, and gut health. It differentiates itself by using grass-fed whole milk rather than skim milk, a patented protein blend, and strong quality standards validated by the Clean Label Project Purity Award. The goal is to provide safe, high-quality infant nutrition that closely mirrors breast milk and to broaden access through trusted retail partnerships.
Company Size
51-200
Company Stage
Late Stage VC
Total Funding
$349.2M
Headquarters
New York City, New York
Founded
2016
Simplify's Take
What believers are saying
- Full refunds offered for purchases since August 1, 2025, rebuilding trust.
- Paused production to prioritize family support and investigation.
- IEH labs identified botulism for root cause analysis improvements.
What critics are saying
- Botulism outbreak hospitalized 37 infants across states since August 2025.
- FDA links ByHeart formula to 40% of 84 national cases despite 1% market.
- Prior Cronobacter sakazakii contamination in 2022 erodes safety credibility.
What makes ByHeart unique
- ByHeart uses patented protein blend from organic grass-fed whole milk.
- Clinically proven for easier digestion, less spit-up, softer poops.
- Received Clean Label Project Purity Award for 400 contaminants.
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Benefits
Health Insurance
Dental Insurance
Vision Insurance
Unlimited Paid Time Off
Parental Leave
401(k) Company Match
Company Equity
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6 month growth
↑ 2%1 year growth
↑ 8%2 year growth
↑ 10%ByHeart expands nationwide recall of infant formula after uptick in botulism cases. ByHeart Inc. has expanded a voluntary recall of its infant formula nationwide as federal investigators continue to examine a spike in infant botulism cases, the company said in a news release from the U.S. Food and Drug Administration (FDA). The action affects all batches of ByHeart Whole Nutrition Infant Formula 24 oz cans and 0.6 oz Anywhere Pack packets. The recall includes Alabama, where the products are sold through national distribution channels. The company said in the release that no unopened ByHeart product has tested positive for Clostridium botulinum spores or toxin, yet it broadened the recall as a precaution while the FDA and the Centers for Disease Control and Prevention review a surge of 84 infant botulism cases reported since August. "The safety and well-being of every infant who uses our formula is, and always will be, our highest priority," Mia Funt, ByHeart co-founder and president, said in the release. "This nationwide recall reflects our commitment to protecting babies and giving families clear actionable information. Alongside this recall, we are conducting a comprehensive investigation to do our part to get the answers parents expect and deserve." The FDA alerted ByHeart to the broader investigation on Nov. 7. The company said it is recalling all product from the market while federal officials work to identify a root cause of the outbreak. ByHeart also said it has begun sending every batch of formula to an independent laboratory for testing, has given FDA and California Department of Public Health teams unrestricted access to its facilities and unopened cans, and will publish test results from regulators and independent analysts as they become available. The Alabama Department of Agriculture and Industries (ADAI) said their food safety inspectors are conducting recall effectiveness checks. "ADAI is working closely with the Alabama Department of Public Health, CDC and FDA to be sure all remaining products are removed from store shelves," said Agriculture and Industries Commissioner Rick Pate. "The health and safety of children is our top priority." After inspecting a total of 93 stores, ADAI food safety inspectors have collected 57 products from 10 separate locations. The recall covers every batch of the affected formula. Product identifiers listed in the release include the ByHeart Whole Nutrition Infant Formula can UPC 85004496800 and the Anywhere Pack UPC 85004496802. Officials urged consumers to check packaging carefully to verify whether they purchased recalled items. Infant botulism is a rare but serious illness caused when Clostridium botulinum spores colonize an infant's intestinal tract. Symptoms can include constipation, poor feeding, drooping eyelids, sluggish pupils, low muscle tone, difficulty sucking and swallowing, weak or altered cry, generalized weakness, breathing problems and possible respiratory arrest. Medical attention should be sought immediately if these signs appear. Consumers should stop using and dispose of any ByHeart formula affected by the recall. Illnesses or adverse events can be reported through an FDA Consumer Complaint Coordinator, an electronic Voluntary MedWatch form or a paper MedWatch form mailed to the agency. Parents with questions can reach ByHeart at [email protected] or call (833) 429-4327. More information is available at www.byheart.com or on the FDA website at www.fda.gov.
Recall roundup: baby formula, costco wine, Honda Civics lead the list. Several consumer goods, food products and vehicles were recalled over the past week, including a popular baby formula that has led to 15 infant hospitalizations. Here's a look at various recalls that have been issued in the past week. A baby formula recall has been expanded after two more infants were hospitalized this week connected to a botulism outbreak, according to the Centers for Disease Control and Prevention. The CDC and U.S. Food and Drug Administration and public health officials in several states have been investigating a botulism outbreak linked to formula - which has led to a recall of products from ByHeart Inc. After two more infant hospitalizations were reported in the United States this week, ByHeart Inc. recalled all ByHeart Whole Nutrition infant formula products on Tuesday. There are now 15 reported cases - which were all hospitalizations - across 12 states. The CDC urged parents and caregivers to stop using any ByHeart Whole Nutrition infant formula immediately. This includes all lot numbers and all sizes of cans and single serve packets. The baby formula is available for sale online and at major retailers nationwide. Infant botulism occurs when swallowed spores from a type of bacteria called Clostridium botulinum infects a baby's large intestine and produces a toxin. Infant botulism often starts with constipation, but is usually first noticed as difficulty feeding (sucking and swallowing), a weak and altered cry, and loss of muscle tone, according to the CDC. Parents and caregivers should not use any ByHeart Whole Nutrition infant formula. If possible, record the lot number and best by date. Wash items and surfaces that may have touched the formula with hot soapy water or a dishwasher. Seek immediate medical care if your infant has consumed this formula and has any of these symptoms: * Poor feeding * Loss of head control * Difficulty swallowing * Decreased facial expression "Symptoms of infant botulism can take as long as several weeks to develop, so parents should remain vigilant if they used ByHeart Whole Nutrition infant formula," stated the CDC. Consumers with questions can contact ByHeart at [email protected], visit byheart.com, or call 1-833-429-4327. Costco has issued a recall for nearly 1 million bottles of a popular wine. F&F Fine Wines International is recalling approximately 941,000 Kirkland Signature Valdobbiadene Prosecco DOCG bottles, as the bottles can break or shatter, posing a laceration risk. There have been 10 reports of the bottles shattering or breaking, resulting in one laceration injury, according to the U.S. Consumer Product Safety Commission. The product was sold in a green bottle with purple foil on the top and a purple label with the words "Kirkland Signature Valdobbiadene Prosecco Superiore DOCG" featured. The wine was priced at about $8 per bottle. It was sold in mostly Midwest stores from April through August 2025. If you have a recalled bottle, stop use immediately and discard in your household trash. Contact F&F Fine Wines at 786-810-7132 or email [email protected], for questions regarding this recall. Honda has issued a safety recall because of an accessory sold for one of its most popular car models. Around 406,290 vehicles are affected by the recall, according to the National Highway Traffic Safety Administration. Documents filed with the highway safety agency stated that 18-inch alloy wheels that were sold as accessories for the ever-popular Honda Civic could detach from the vehicle. The issue stems from lug nuts on the wheels that were not properly installed during production. The wheel nuts could loosen and detach while operating the vehicle, increasing the risk of a crash. The recall currently impacts Honda Civics sold under model years from 2016 to 2021 with the optional 18-inch aluminum alloy wheels. Owners will be contacted by Honda to bring their vehicle into a dealership. There, dealers will inspect and replace the hubs and wheels as necessary, free of charge. The manufacturer will begin contacting vehicle owners by mail on Dec. 8. Honda owners can also call the National Highway Traffic Safety Administration's safety hotline at (888) 327-4236 to see if they are affected by the recall. Parents are being warned about certain children's toys that are being recalled due to major safety concerns, according to a notice posted by the U.S. Consumer Product Safety Commission. About 64,000 Inkari Plush Alpaca Toys have been recalled because the eyes on the dolls can detach and pose a choking hazard, especially to young children. The products were sold from November 2020 through July 2025 on websites like Amazon and Etsy, and were marketed for children under three years old. The stuffed wool toys were sold in four different sizes: the 6-inch mini, the 9-inch small, the 12-inch medium and the 19-inch large. The recall covers five color collections of the plush alpaca toys: naturals, baristas, rainbow, monsterfluffs, and limited edition, according to the CPSC. Consumers are being advised to immediately stop using the recalled plush toys and contact the manufacturer for a full refund. To qualify for the refund, owners will be asked to cut the fur of the toy and send a photo to a company-operated email. The Inkari company can be reached via email at [email protected]. So far, no injuries have been reported in connection with the toys. Vevor is recalling about 1,020 baby swings sold across the U.S. due to a serious safety hazard that violates federal standards and poses a risk of infant suffocation, according to the U.S. Consumer Product Safety Commission. The recalled Vevor Baby Swings were marketed for infant sleep and feature an incline angle greater than 10 degrees, which violates the mandatory safety standard for infant sleep products and the ban on inclined sleepers under the Safe Sleep for Babies Act. While no injuries have been reported, the CPSC warns that the product poses a deadly suffocation risk and urges consumers to stop using the swings immediately. The recall includes white/gray and black/gray swings labeled "Multi-Function Electric Swing" with model numbers BB501K, BB702A, and BB005K. The swings were sold online at Vevor.com and Amazon.com between January and August 2025 for $65 to $80. Consumers should contact Sanven Technology for a full refund. To complete the process, users must remove the swing cover, cut it in half, write "Recalled" on the base with a permanent marker, and send a photo of the destroyed product to [email protected]. For more information, visit vevor.com and click "Product Recall" at the top of the homepage. The U.S. Food and Drug Administration has updated the risk level for about 23,000 pounds of pre-cooked scrambled egg products that were recently recalled due to the potential presence of a dangerous bacteria. The agency recently classified recalled Echo Lake Foods Cage Free Precooked Scrambled Eggs as a Class I recall on Nov. 6, which is the most serious health risk classification. According to the FDA, a Class I recall is a "situation in which there is a reasonable probability that the use of, or exposure to, a violative product will cause serious adverse health consequences or death." A recall of these items was made on Oct. 23, as the products could be contaminated with Listeria monocytogenes. It involves products with lot number 5164 and an expiration date of Dec. 13, 2026. The egg products were sold to consumers in California, who were informed of the recall by letter. Listeria is an organism that can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems, according to the FDA. While healthy individuals may suffer only short-term symptoms, such as high fever, severe headache, stiffness, nausea, abdominal pain and diarrhea, listeria infection can cause miscarriages and stillbirths among pregnant women.
ByHeart recall: Arizona family sues baby formula maker. One Arizona family is suing ByHeart baby formula after their baby was hospitalized with botulism, following a nationwide recall. The brief. * * A family in Flagstaff is suing ByHeart, which makes a popular organic baby formula. * All ByHeart products are being recalled amid an infant botulism outbreak. * "They're concerned about their kid, and they're concerned about making sure their bills are paid," said a lawyer representing the Flagstaff family. PHOENIX - The nationwide recall of a popular baby formula has been expanded as more infants are hospitalized, and now, an Arizona family is now suing the formula's maker. On Nov. 10, it was reported that ByHeart announced a voluntary recall of some of its powdered infant formula, after the product was tied to an infant botulism outbreak. One day later, on Nov. 11, officials with the Food and Drug Administration announced that all baby formula products by ByHeart are recommended for recall. On Nov. 14, FDA officials said there are "a total of 23 infants with suspected or confirmed infant botulism and confirmed exposure to ByHeart Whole Nutrition infant formula (various lots) have been reported from 13 states." According to CDC data, there are three cases in Arizona. Neighboring California also has three cases. ByHeart baby formula grew in popularity as one of the first organic grass-fed baby formulas approved by the FDA. It comes with an expensive price tag, costing upwards of $40 a can. The company sold over 200,000 cans of formula per month nationwide. Stephen Dexter's family is among those affected by the baby formula. "I wish I had taken her to the doctor, so it's a little closer, a little sooner," said Dexter. Dexter can't help but feel guilty for trusting the baby formula for his one-month-old first child, Rose. "I went to pick her up to feed her, and I couldn't wake her up," Dexter recounted. "She was breathing, but she just - she wouldn't wake up." Rose was lifeflighted from Flagstaff to Phoenix Children's Hospital, and spent two weeks in the ICU with botulism. Food safety lawyer Bill Marler is representing the Dexters as they sue ByHeart. "They're concerned about their kid, and they're concerned about making sure their bills are paid," said Marler. "They're also pissed. They're angry. They're very angry about what happened, and they want to have answers." Per the lawsuit, ByHeart's facilities were flagged multiple times by the FDA over the last four years, alongside reports of deadly bacteria contamination, water leaks, and dead insects. "I think most of the public would be shocked that there's not an inspector in every infant formula plant on a daily basis," Marler said. "These companies need to be reminded that they have a sacred trust with consumers. When you go to a grocery store, you're not thinking, 'my god, what am I going to buy that could possibly kill my kid?' You're not thinking about that." Constipation, poor feeding, difficulty swallowing, and lethargy are signs to look out for in botulism infections. Health experts say it can take up to 30 days for signs of infantile botulism infection to appear. The Source: Information for this article was gathered by FOX 10's Kenzie Beach.
ByHeart recalls all infant formula amid botulism outbreak. Fifteen infants across twelve states have been hospitalized with botulism after consuming ByHeart formula - a brand that represents less than 1% of the U.S. infant formula market but accounts for 40% of the 84 botulism cases treated nationwide since August. The question isn't whether ByHeart acted fast enough after the FDA alert on November 7. It's how a premium startup formula brand, founded in 2016 with backing from Polaris Partners and H&S Ventures, became the center of the first major formula safety crisis since Abbott's 2022 shutdown. ByHeart positioned itself as the anti-establishment formula company. The founders, Mia Funt and Ron Belldegrun, built their brand on clean-room manufacturing and third-party testing protocols that exceeded FDA requirements. Their Pennsylvania facility opened in 2019 with $90 million in funding and promises to match European safety standards. Now every batch they've produced sits under recall. The timeline matters here. The first infant fell ill on August 9. By early November, cases had spread from Arizona to Rhode Island, with victims ranging from 16 days to 5 months old. The California Department of Public Health Infant Botulism Treatment and Prevention Program flagged the pattern: too many cases, same formula, different states. ByHeart's response on November 8 started narrow - two specific batch codes. Four days later, they pulled everything. The company maintains no unopened product has tested positive for Clostridium botulinum spores. They've opened their facilities to California health inspectors and started retesting every batch through independent labs. The FDA's investigation continues alongside the CDC and state agencies. No deaths have been reported, but infant botulism can cause respiratory arrest. Parents watching for symptoms - constipation, weak crying, drooping eyelids, difficulty swallowing - face a weeks-long window before signs appear. ByHeart response timeline scrutiny. For entrepreneurs in the food safety space, this case exposes the gap between premium positioning and actual risk management. ByHeart's marketing emphasized their "next-generation" approach, their clinical trials, their grass-fed milk sourcing. None of that prevented whatever contamination pathway led to this outbreak. The business impact extends past the immediate recall costs. ByHeart had been expanding distribution through Target and Whole Foods, competing against established players like Enfamil and Similac. Their direct-to-consumer subscription model, which promised parents consistent supply after the 2022 shortage, now faces a trust deficit that venture funding can't fix. The strongest counter-argument: correlation isn't causation. These 15 cases could share another exposure source not yet identified. The FDA hasn't found contamination in sealed products. ByHeart's manufacturing processes might prove sound once testing completes. But the numbers create their own momentum. When 40% of national botulism cases trace to a 1% market share brand, the statistical anomaly demands explanation. Either ByHeart has a contamination problem, or their customer base has unique risk factors nobody's identified. What changes Monday: Any food startup planning to challenge incumbents needs contamination insurance that covers not just recall costs but brand rehabilitation. The premium positioning that commands higher prices becomes a liability when safety questions arise. Parents who paid $39 for a 24-ounce can expected better than this. The lesson for innovators is stark - regulatory compliance sets the floor, not the ceiling, for food safety systems. When your entire brand promise rests on being better than the giants, one outbreak can erase years of trust-building faster than any marketing campaign can rebuild it. Why trust inventorspot. Its team of innovation experts take great pride in the quality of its content. Its writers create original, accurate, engaging content that is free of ethical concerns or conflicts. Its rigorous editorial process includes editing for accuracy, recency, and clarity. Jeff is an expert in innovation. He writes on creativity and how businesses can grow their inventiveness. About inventorspot. InventorSpot is the #1 publication on the web focused on innovation, inventing. and the future of technology. With over 80,000+ followers across social media, the site has become one of the top hubs for technology discussion and more. If you have any questions or concerns about its articles, please contact Inventorspot, LLC. Become a smarter inventor in just 5 minutes, weekly.
ByHeart recalls all baby formula products amid botulism outbreak. ByHeart, a manufacturer of organic baby formula, recalled all of its products sold nationwide Tuesday, days after some batches were recalled in an expanding outbreak of infant botulism. At least 15 babies in 12 states have been sickened in the outbreak since August, with more cases pending, according to state and federal health officials. All of the infants were hospitalized after consuming ByHeart formula, officials said. No deaths have been reported. ByHeart officials expanded the voluntary recall from two lots announced Saturday to all products in consumers' homes and in stores. That includes ByHeart Whole Nutrition Infant Formula and Anywhere Pack pouches of powdered formula. The company sells about 200,000 cans of infant formula a month online and in stores such as Target, Walmart, Albertsons and Whole Foods, according to Dr. Devon Kuehn, chief medical officer. Parents and caregivers who have the formula in their homes "should immediately discontinue use and dispose of the product," Kuehn said. Company officials said they enacted the unusual recall "in close collaboration" with the U.S. Food and Drug Administration even though no product that was previously unopened tested positive for the contamination. The type of bacteria that produces the toxin is widespread in the environment and could come from sources other than the formula, company officials said. "This action underscores ByHeart's core mission: protecting babies above all else," the company said in a statement. California health officials earlier confirmed that a sample from an open can of ByHeart baby formula fed to an infant who got sick contained the toxin-producing type of bacteria. The U.S. Food and Drug Administration recommended that ByHeart expand its recall because of the number of ill infants that reported consuming the formula, the identification of additional lot codes, the growing case count and the results of the California testing. The FDA is investigating 84 cases of infant botulism detected since August. Of those, 15 consumed ByHeart formula, the agency said in a statement. "This information shows that ByHeart brand formula is disproportionately represented among sick infants in this outbreak, especially given that ByHeart represents an estimated 1% of all infant formula sales in the United States," the FDA statement said. Illnesses began between Aug. 9 and Nov. 10, federal officials said. Cases were reported in Arizona, California, Illinois, Kentucky, Minnesota, North Carolina, New Jersey, Oregon, Pennsylvania, Rhode Island, Texas and Washington. Investigators have not identified any other infant formula brands or other sources of exposure in the outbreak, officials said. ByHeart produces formula powder at a plant in Allerton, Iowa, and then ships it to a site in Portland, Oregon, for canning and distribution, Kuehn said. U.S. Food and Drug Administration inspectors were at the Portland plant Monday, she added. In addition to the broad recall, the company said it is testing every batch of formula with an independent third-party laboratory, providing health officials full access to its sites and sharing results with regulators as they become available. Infant botulism is a rare and serious illness that occurs in babies under age 1, whose gut microbiomes are immature. It is caused when the infants consume bacteria that contain spores that produce a toxin in the gut. Symptoms include constipation, poor feeding, drooping eyelid, weak muscle tone, difficulty swallowing and breathing problems, among others. Babies who develop those symptoms need immediate medical attention. The sole treatment for the infection is BabyBIG, an IV medication made from blood plasma of people immunized against botulism. The Associated Press Health and Science Department receives support from the Howard Hughes Medical Institute's Department of Science Education and the Robert Wood Johnson Foundation. The AP is solely responsible for all content. More in nation-world news. If you purchase a product or register for an account through a link on our site, we may receive compensation. By using this site, you consent to our User Agreement and agree that your clicks, interactions, and personal information may be collected, recorded, and/or stored by us and social media and other third-party partners in accordance with our Privacy Policy.