A

Axogen

Specializes in peripheral nerve repair devices

Senior Quality Engineer

Full-TimeUpdated on 10/20/2026
$84.2k - $110k+ Annual bonus
Senior
Bachelor of Science (BS)
Vandalia, OH, USA
In Person
Biology & BiotechRegulatory & Quality (Life Sciences)

About the job

Requirements
  • Bachelor of Science degree in Biomedical Engineering, Mechanical Engineering, or Engineering Technology.
  • Knowledge of lean/progressive manufacturing and quality disciplines.
  • Fundamental understanding of design controls, project management, and basic manufacturing practices and processes.
  • At least five years of experience in a Quality Engineering or Quality Assurance role within medical device or pharmaceutical manufacturing.
  • Project management skills.
  • Knowledge of statistical sampling and analysis.
  • Proficiency with the Microsoft Office suite, including Microsoft Visio and Microsoft Project.
  • Experience with limit gauge design for dimensional verification.
  • Ability to solve problems using root-cause methodologies, including Define, Measure, Analyze, Improve, Control (DMAIC).
  • Ability to apply statistics and software in data analysis, including Minitab.
  • Knowledge of failure modes and effects analysis (FMEA).
  • Experience working with suppliers to design inspection systems and resolve quality issues.
  • Knowledge of quality-system regulations and requirements, including 21 CFR Parts 820, 1271, and 210/211; ISO 13485; ISO 9001; and ISO 14971.
  • Experience with geometric dimensioning and tolerancing (GD&T).
  • Ability to travel up to 30%.
  • Compliance with applicable healthcare-system credentialing, vaccination, and employment/compliance requirements.
Responsibilities
  • Confer with external and internal departments, including Product Development, Clinical, Marketing, Sales, and Operations, on product design to ensure user needs are met.
  • Evaluate product designs for manufacturability and recommend design-process adjustments and quality improvements.
  • Select, develop, and qualify or validate tools, fixtures, machinery, and equipment used in manufacturing.
  • Lead and participate in risk-management activities.
  • Lead quality-issue resolution using root-cause methodologies.
  • Ensure effective design control and transfer to production.
  • Lead quality-planning activities for new product development projects, including verification and validation plans and reliability strategies.
  • Lead quality-planning activities for facility development, including verification and validation plans and reliability strategies.
  • Lead quality-planning activities for new and existing processes, including verification and validation plans and reliability strategies.
  • Investigate manufacturing processes to reduce nonconformance and optimize inspections.
  • Identify statistical methods relevant to manufacturing processes to determine quality-improvement parameters.
  • Prepare reports and presentations by collecting, analyzing, and summarizing data and making recommendations.
  • Collaborate with supply-chain partners to assure product quality.
  • Work with purchasing and logistics to maintain the supplier-management program.
  • Design and implement inspection methods, equipment, acceptance criteria, and sampling plans.
  • Initiate or assist with product-inspection cost reductions.
  • Provide validation, sampling, and statistical-analysis support to other organizational functions.
  • Perform first article inspections to ensure manufacturing-process capability.
  • Ensure compliance with current good manufacturing practices, Quality System Regulation, ISO 13485, Medical Device Directive, and other applicable regulations and standards.
  • Participate in Food and Drug Administration inspections, ISO certification, surveillance audits, and customer audits.
  • Deploy proactive quality controls for consistent and predictable quality outcomes.
  • Establish and implement metrics to monitor system effectiveness.
  • Report quality issues, trends, and losses to management.
  • Provide functional support to team members as needed.
  • Direct staff as needed.
Desired Qualifications
  • American Society for Quality Certified Quality Engineer certification.
  • Lead auditor certification.
  • Six Sigma Black Belt certification.

About the company

A

Axogen

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Website

Axogen develops and sells surgical solutions specifically for repairing peripheral nerve damage. The company’s products, such as the Avance Nerve Graft, work by using processed human donor tissue to bridge gaps in severed nerves, while its Axoguard line provides protective wraps and connectors to shield nerves during the healing process. Unlike traditional methods that require a second surgery to harvest a patient's own healthy nerve, Axogen provides ready-to-use grafts that eliminate additional surgical trauma and potential lasting damage at a donor site. The company's goal is to provide surgeons with a comprehensive platform of clinically proven tools to restore nerve function and improve the quality of life for patients with nerve injuries.

Company Size

501-1,000

Company Stage

IPO

Headquarters

Alachua, Florida

Founded

2002

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Simplify's Take

What believers are saying

  • Q2 2026 revenue rose 23.1% to $69.7 million; guidance lifted to $279 million.
  • Breast reconstruction drove over half of Q2 sales and expanded surgeon penetration.
  • September 2026 equity financing fully funds BioCircuit, preserving a cleaner balance sheet.

What critics are saying

  • Avance accelerated approvals depend on a confirmatory study through 2031; failure risks withdrawal.
  • September 2026 BioCircuit closing depends on note conversion, IP consent, and spin-out completion.
  • Q2 2026 gross margin fell to 72.7% while operating expenses reached $52.8 million.

What makes Axogen unique

  • Dec. 3, 2025 FDA BLA approval gives Avance durable regulatory credibility.
  • Axogen owns the only focused peripheral nerve repair platform spanning grafts, protectors, caps.
  • BioCircuit's NerveTape acquisition adds the first FDA-approved sutureless nerve repair device.

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Benefits

  • Health Insurance
  • Dental Insurance
  • Vision Insurance
  • 401(k) Company Match
  • Paid Vacation
  • Paid Holidays
  • Employee Stock Purchase Plan
  • Tuition Reimbursement
  • Paid Parental Leave
  • Paid Caregiver Leave
  • Basic Life Insurance
  • Supplemental Life Insurance

Growth & Insights and Company News

Headcount

6 month growth

12%

1 year growth

14%

2 year growth

14%
Foreign Policy Journal
Oct 4th, 2026
Nasdaq Composite surges on tech strength while (NYSE: RTX), (NASDAQ: IART), (NASDAQ: PECO) and (NASDAQ: AXGN) make market moves.

Nasdaq Composite surges on tech strength while (NYSE: RTX), (NASDAQ: IART), (NASDAQ: PECO) and (NASDAQ: AXGN) make market moves. Big technology drove the Nasdaq Composite to a weekly gain as the Dow Jones Industrial Average and Russell 2000 both closed the week in negative territory. The Nasdaq Composite jumped 1.18% on the day to close at 27,188.02, posting a weekly gain of 0.44% as chip and software names led the advance. The Dow Jones Industrial Average finished at 51,094.96, up 0.33% on the day but down 1.42% for the week, with an RSI14 of 38.1 signaling a weakening trend. The S&P 500 settled at 7,719.34, gaining 0.69% on Friday but slipping 0.31% for the week, while the Russell 2000 rose 0.97% on the day to 2,833.74 but edged down 0.13% for the week. The CBOE Volatility Index fell to 15.58, down 0.81 on the day, while WTI crude oil dropped 2.48% on the day and 2.19% for the week to settle at $90.57 a barrel. Gold eased 0.85% on the day to $4,166.60 an ounce, silver fell to $60.40, and the US 10-year Treasury yield rose 8 basis points for the week to 5.26%. RTX (NYSE: RTX) saw its Raytheon division secure a five-year contract with two additional option years valued at up to $24.4 billion for Standard Missile-6 interceptors for the U.S. Navy. Phil Jasper, Raytheon President, said: "SM-6's multi-mission capability is vital to our customer, and Raytheon is intensely focused on meeting the demand." Integra LifeSciences Holdings Corporation (NASDAQ: IART) provided preliminary third-quarter results, citing ongoing impact from a July flooding event at its Cincinnati facility, with expected revenue of approximately $410 million to $412 million. Stuart Essig, Chairman and Chief Executive Officer, said: "Our third quarter results were impacted by the July flooding event at our Cincinnati facility. Our teams have made significant progress executing recovery plans and supporting customers." IART lowered its full-year 2026 revenue outlook to $1.634 billion to $1.654 billion and cut adjusted EPS guidance to $2.30 to $2.40, while still targeting $190 million to $200 million in operating cash flow. Trilogy Metals Inc. (NYSE American: TMQ) reported a cash balance of $31.2 million as of August 31, 2026, and announced the closing of a $35.6 million strategic equity investment from the Department of War on September 11, 2026. Tony Giardini, President and CEO of Trilogy Metals, said: "The third quarter and the weeks that followed have been transformational for Trilogy Metals." Phillips Edison and Company, Inc. (NASDAQ: PECO) reaffirmed its full-year 2026 earnings guidance and raised its gross acquisitions target to $600 million to $700 million after acquiring $459.7 million in assets year to date through September 30, 2026. Jeff Edison, Chairman and Chief Executive Officer, said: "We're pleased to reaffirm our guidance for full year 2026 Core FFO per share growth, which reflects 6.2% year-over-year growth at the midpoint." Axogen, Inc. (NASDAQ: AXGN) completed its acquisition of BioCircuit Technologies, adding NerveTape, described as the first FDA cleared device for sutureless peripheral nerve repair. Michael Dale, President and Chief Executive Officer of Axogen, said: "NerveTape represents a new standard of care as the first sutureless nerve repair option, one that is simpler, faster, and more effective than microsuturing." Axogen expects BioCircuit to contribute approximately $6 million to fourth-quarter 2026 revenue and approximately $34 million to 2027 revenue, with the company maintaining its full-year 2026 guidance of at least 24% revenue growth.

BioPharma Watch
Oct 1st, 2026
Axogen completes acquisition of BioCircuit Technologies, adding NerveTape(TM), the first FDA cleared device for sutureless peripheral nerve repair.

Axogen completes acquisition of BioCircuit Technologies, adding NerveTape(TM), the first FDA cleared device for sutureless peripheral nerve repair. Key Takeaway: Axogen, Inc. has completed its acquisition of BioCircuit Technologies, known for its NerveTape(TM), the first FDA-cleared sutureless device for peripheral nerve repair. This acquisition is expected to significantly enhance Axogen's revenue, contributing approximately $6 million in Q4 2026 and $34 million in 2027. The integration of NerveTape(TM) aligns with Axogen's goal of improving standards in nerve repair. Market sentiment analysis. Positive Factors. * Acquisition enhances Axogen's product offerings with NerveTape(TM). * NerveTape(TM) is the first FDA-cleared sutureless device for nerve repair. * Expected revenue contributions from BioCircuit are significant. * Aligns with Axogen's mission to improve peripheral nerve repair. ALACHUA, Fla. and TAMPA, Fla., Oct. 01, 2026 (GLOBE NEWSWIRE) - Axogen, Inc. ("Axogen" or the "Company") (Nasdaq: AXGN), a global leader in developing and marketing innovative surgical solutions for the restoration of peripheral nerve function, today announced that it has completed its previously announced acquisition of BioCircuit Technologies, Inc. ("BioCircuit"), a privately held medical device company and developer of NerveTape(TM). "This is a significant day for Axogen and the surgeons and patients we serve," said Michael Dale, President and Chief Executive Officer of Axogen. "NerveTape represents a new standard of care as the first sutureless nerve repair option - one that is simpler, faster, and more effective than microsuturing. This innovative technology directly addresses surgeons' everyday need to repair nerves and aligns perfectly with Axogen's mission to make the restoration of peripheral nerve function an expected standard of care. It is therefore an ideal fit with our direct sales organization and hospital contracting capabilities, enabling and unlocking NerveTape's full potential." The Company expects BioCircuit to contribute approximately $6 million to fourth-quarter 2026 and approximately $34 million to 2027 revenue. This contribution was not included in Axogen's most recently issued full-year 2026 guidance of at least 24% revenue growth. The Company continues to expect gross margin to be at least 73% and to be free cash positive for the full-year 2026. About Axogen. Axogen (AXGN) is the leading company focused specifically on the science, development and commercialization of technologies for peripheral nerve regeneration and repair. Axogen employees are passionate about providing the opportunity to restore nerve function and quality of life for patients with peripheral nerve injuries by providing innovative, clinically proven and economically effective repair solutions for surgeons and healthcare providers. Peripheral nerves provide the pathways for both motor and sensory signals throughout the body. Every day people suffer traumatic injuries or undergo surgical procedures that impact the function of their peripheral nerves. Physical damage to a peripheral nerve or the inability to properly reconnect peripheral nerves can result in the loss of muscle or organ function, the loss of sensory feeling, or the initiation of pain. Axogen's product portfolio includes Avance(R)(acellular nerve allograft-arwx), Avance(R) Nerve Graft, Axoguard Nerve Connector(R), Axoguard Nerve Protector(R), Axoguard HA+ Nerve Protector(TM), Axoguard Nerve Cap(R), and Avive+ Soft Tissue Matrix(R). About BioCircuit Technologies. BioCircuit Technologies, based in Atlanta, Georgia, develops and commercializes medical devices for peripheral nerve repair and neuromodulation, with expertise in biomaterials, precision Nitinol design and manufacturing, and bioelectronics for nerve stimulation and recording. Its first commercial product, NerveTape(TM), is the first FDA-cleared sutureless device for repairing transected nerves. BioCircuit has been supported by small business funding from the National Institutes of Health along with private investment from Alsora Capital, GRA Venture Fund, Michael Masters of Masters Capital Management, and other investors. For more information, visit www.biocircuit.com. Cautionary statements concernin g forward-looking statements. This press release contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. All statements other than statements of historical fact contained in this press release are forward-looking statements, including statements regarding Axogen's ability to successfully integrate BioCircuit and realize the anticipated benefits of the acquisition, the expected financial impact of the acquisition and related financial guidance and outlook, including expected revenue, revenue growth, revenue contribution from BioCircuit in the fourth quarter of 2026 and in 2027, gross margin, free cash flow, as well as expectations regarding the commercialization and adoption of NerveTape and the expansion of Axogen's addressable market. In some cases, you can identify forward-looking statements by terms such as "may," "will," "should," "expect," "plan," "anticipate," "could," "intend," "target," "project," "contemplates," "believes," "estimates," "predicts," "potential," "upcoming" or "continue" or the negative of these terms or other similar expressions. These forward-looking statements speak only as of the date of this press release and are subject to a number of risks, uncertainties and assumptions, including the risks and uncertainties related to the integration of BioCircuit and the realization of the anticipated benefits of the acquisition and the risks and uncertainties inherent in Axogen's business, including the risks and uncertainties described in the Company's periodic filings with the SEC. The events and circumstances reflected in the Company's forward-looking statements may not be achieved or occur and actual results could differ materially from those projected in the forward-looking statements. Additional information on risks facing Axogen can be found under the heading "Risk Factors" in Axogen's periodic filings with the SEC, including its annual report on Form 10-K for the year ended December 31, 2025 and in its subsequent quarterly reports on Form 10-Q. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof. Except as required by applicable law, Axogen undertakes no obligation to update or revise any forward-looking statements contained herein. Frequently asked questions. What is NerveTape(TM)? NerveTape(TM) is the first FDA-cleared sutureless device for repairing transected nerves. How much revenue is expected from BioCircuit in 2027? BioCircuit is expected to contribute approximately $34 million to Axogen's revenue in 2027. What does the acquisition mean for Axogen's future? The acquisition enhances Axogen's product offerings and aligns with its mission to improve nerve repair standards. What are the benefits of NerveTape(TM)? NerveTape(TM) offers a simpler, faster, and more effective option for nerve repair compared to traditional microsuturing.

Axogen, Inc.
Sep 21st, 2026
Axogen Enters into Definitive Agreement to Acquire BioCircuit Technologies

Acquisition adds NerveTape™, the 1st FDA-approved device for sutureless peripheral nerve repair, broadening Axogen’s addressable market within…...

StockTitan
Sep 10th, 2026
Axogen, Inc. 424B filings.

Axogen, Inc. 424B filings. AXGN NASDAQ Every 424B that Axogen, Inc. (AXGN) has filed with the SEC in the last 12 months is listed below, newest first, and each one links through to the document itself with the summary and the scores our analysis gives it. A 424B covers the supplement that carries the terms of a priced offering, so if you follow AXGN and want that one kind of document rather than the whole filing history, this is the page to keep. The company's other filings, of every form, are on the full AXGN filings page. 09/10/2026 04:56 PM Rhea-AI Summary Axogen, Inc. (AXGN) is conducting a primary offering of 4,910,000 shares of common stock at a public offering price of $42.50 per share, for gross proceeds of $208.7 million and estimated net proceeds of about $195.5 million after fees and expenses. Underwriters have a 30-day option to buy up to 736,500 additional shares. Shares outstanding will increase from 53,656,293 as of June 30, 2026 to 58,566,293 (or 59,302,793 if the option is fully exercised). The company plans to use substantially all net proceeds to fund the $200.0 million cash purchase of BioCircuit Technologies, Inc. and related costs, with any remainder for general corporate purposes; if the acquisition is not completed, all proceeds will be used for general corporate purposes. New investors face immediate dilution, as net tangible book value rises from $4.63 to $7.58 per share versus the $42.50 offering price. 01/23/2026 07:00 AM Rhea-AI Summary Axogen, Inc. is conducting a public offering of 4,000,000 shares of common stock at $31.00 per share, with underwriters holding a 30-day option to buy up to 600,000 additional shares. The company expects net proceeds of about $115.9 million (or $133.3 million if the option is fully exercised) and plans to use roughly $69.7 million to repay and terminate its Oberland credit facility, with the balance for working capital and capital spending. Axogen reports preliminary 2025 revenue of about $225.2 million, up roughly 20.2% year over year, and fourth-quarter revenue of about $59.9 million, up about 21.3%. Gross margin for 2025 and the fourth quarter is expected to be above 74%, including approximately $1.9 million in largely non-cash one-time costs tied to FDA approval milestones. On December 3, 2025, the FDA approved Axogen's Biologics License Application for Avance, an acellular nerve scaffold for specific sensory, mixed, and motor nerve indications, with certain uses granted under the accelerated approval pathway and subject to a confirmatory post-marketing study. 01/21/2026 04:59 PM Rhea-AI Summary Axogen is offering $85 million of common stock in a primary equity raise. The company has also granted underwriters a 30-day option to buy up to an additional $12.75 million of shares. Axogen currently intends to use a significant portion of the net proceeds to make an early payoff of its Oberland credit facility, with a final repayment amount expected to be approximately $69.7 million, which would terminate all obligations under that debt. Alongside the financing, Axogen outlines strong preliminary 2025 results, with expected revenue of about $59.9 million for the fourth quarter and $225.2 million for the full year, increases of 21.3% and 20.2% versus 2024. Gross margin for 2025 is expected to be above 74%, despite about $1.9 million of one-time costs tied to FDA approval of its Avance biologic. The company ended 2025 with approximately $45.5 million in cash, cash equivalents, restricted cash and investments, up about $6.0 million from a year earlier. The FDA approved Axogen's Biologics License Application for Avance in December 2025, granting full approval for certain sensory nerve indications and accelerated approval for longer sensory and mixed and motor nerve repairs, subject to a confirmatory post-marketing study running through 2030 with a final report due in 2031.

Citybiz
Sep 10th, 2026
Axogen prices $208.7 million stock offering to fund BioCircuit acquisition.

Axogen prices $208.7 million stock offering to fund BioCircuit acquisition. September 10, 2026 Axogen Inc. has priced an underwritten public offering of 4.91 million shares of common stock at $42.50 per share, seeking approximately $208.7 million in gross proceeds primarily to finance its previously announced acquisition of BioCircuit Technologies Inc. The peripheral nerve repair company, which is based in Alachua and Tampa, Florida, and trades on Nasdaq under the ticker AXGN, is selling all of the shares in the offering. The $208.7 million figure is before underwriting discounts, commissions and other offering expenses and assumes the underwriters do not exercise their option to purchase additional shares. Axogen has granted the underwriters a 30-day option to acquire up to another 736,500 shares at the public offering price, less underwriting discounts and commissions. The transaction is expected to close Sept. 11, subject to customary closing conditions. Substantially all of the net proceeds are expected to fund the cash consideration for Axogen's acquisition of BioCircuit Technologies and related transaction fees and expenses. Any remaining capital would be available for general corporate purposes, including working capital and capital expenditures. The equity raise provides Axogen with a direct financing path for the BioCircuit transaction while preserving flexibility if the acquisition does not close. The stock offering is not contingent on completion of the acquisition. If the BioCircuit deal is not consummated, Axogen plans to redirect the proceeds toward general corporate purposes, including working capital and capital spending. BofA Securities, Jefferies and Wells Fargo Securities are serving as lead book-running managers for the offering. Mizuho Securities USA is also acting as a bookrunner, while Lake Street Capital Markets is serving as co-manager. The financing comes as Axogen continues to build its business around surgical products for peripheral nerve repair and regeneration. The company develops and commercializes technologies intended to help surgeons restore peripheral nerve function following traumatic injuries and surgical procedures. Peripheral nerves carry motor and sensory signals throughout the body, making effective repair important when nerves are damaged or cannot be properly reconnected. Such injuries can result in loss of muscle or organ function, diminished sensation or pain, creating a specialized clinical market for nerve reconstruction and protection technologies. Axogen's existing portfolio includes Avance, an acellular nerve allograft, as well as Avance Nerve Graft, Axoguard Nerve Connector, Axoguard Nerve Protector, Axoguard HA+ Nerve Protector, Axoguard Nerve Cap and Avive+ Soft Tissue Matrix. The products address different aspects of peripheral nerve repair and surgical management. The proposed financing effectively links Axogen's capital markets activity with its acquisition strategy. By raising equity to cover substantially all of the cash consideration and associated costs for BioCircuit, the company is positioning itself to complete the transaction without making the offering dependent on the acquisition's closing. The offering is being conducted under Axogen's effective shelf registration statement on Form S-3ASR filed with the Securities and Exchange Commission on Jan. 21, 2026. The company said it will file a final prospectus supplement and accompanying prospectus with the SEC containing additional information about the transaction. The final size of the capital raise could increase if the underwriters exercise some or all of their option for the additional 736,500 shares. For Axogen, the offering provides capital for the BioCircuit acquisition while also creating a potential source of additional working capital and investment capacity as it continues to commercialize its peripheral nerve repair portfolio.