---
title: 'Sr. Engineer, Quality at Axogen'
canonical: 'https://feeny.ai/job/sr-engineer-quality-axogen-vandalia-ohio-ejn9rtp2sjsq'
type: 'job'
last_seen: '2026-09-09'
---

# Sr. Engineer, Quality at Axogen

- **Company:** Axogen
- **Location:** Vandalia Ohio, United States
- **Compensation:** $84k–$105k
- **Posted:** 2026-08-31
- **Last confirmed live:** 2026-09-09
- **Apply:** https://www.axogeninc.com/about-axogen/careers/?gh_jid=8743487002

## Job description

Axogen is committed to building and maintaining a strong and gratifying company culture that fosters professional growth. Our hands-on and personal approach makes transitioning to a new job a seamless and enjoyable process. Most benefits are effective on day one!

Axogen is an equal opportunity employer and does not discriminate against applicants on the basis of race, color, creed, religion, ancestry, age, sex, marital status, national origin, disability or veteran status.

Why you’ll love working at Axogen:

- Friendly, open, and fun team culture that values unique perspectives
- Company-wide dedication to profoundly impacting patients’ lives
- Comprehensive, high-quality benefits package effective on date of hire
- Educational assistance available for all employees
- Matching 401(k) retirement plan
- Paid holidays, including floating holidays, to be used at your discretion
- Employee Stock Purchase Plan
- Referral incentive program

Axogen Mission and Business Purpose

Our business purpose is to restore health and improve quality of life by making restoration of peripheral nerve function an expected standard of care. We aim to lead the markets we serve by always requiring the solutions we offer patients and caregivers provide an improved benefit-to-risk profile as compared to existing standards of care. To ensure we deliver improved benefit-to-risk solutions, we will guide and expect the market and design requirement specifications underlying our engineering, business development, and clinical research activities, objectively target advancements in standards of care.

Job Summary of the Sr. Engineer, Quality

The Sr. Quality Engineer will provide Quality and Compliance related support for the development, manufacture and distribution of healthcare products in accordance with applicable Quality Management regulations (International and Domestic regulations for Biologic, Human Tissue, Medical Device products) The Sr. Engineer exercises independent judgment in engineering methods, techniques and evaluation criteria for obtaining results, creates formal networks involving coordination among groups, and has broad expertise or unique knowledge in Engineering. The Sr. Engineer may have a small group of direct reports and uses skills to contribute to development of company objectives

## Requirements of the Sr. Engineer, Quality

- Minimum of Bachelor of Science Degree in Biomedical, Mechanical Engineering, or Engineering Technology
- Lean/Progressive Manufacturing and Quality disciplines.
- Fundamental understanding of design controls, project management, and basic manufacturing practices/processes
- Minimum of 5 years in a Quality Engineering/Quality Assurance role for medical device or pharmaceutical manufacturing.
- Strong project management skills required.
- Demonstrated knowledge of statistical sampling and analysis.
- Demonstrated excellent organizational, writing and verbal communication skills
- Proficient with the MS Office Suite, including Microsoft Visio and Project.
- Limit gauge design for dimensional verification.
- Problem solving using root cause methodologies (i.e. DMAIC);
- Applying statistics and software in data analysis (example Minitab)
- Application of failure modes and effects analysis (FMEA);
- Working with suppliers to design inspection systems and resolve quality issues.
- Quality system regulations and requirements (examples 21 CFR part 820, 21 CFR Part 1271, 21 CFR Part 210/211, ISO 13485, ISO 9001, ISO 14971)
- Geometric Dimensioning and Tolerance (GD&T) experience
- Desirable but not required:
- ASQ Certified Quality Engineer
- Lead auditor certification
- Six Sigma Black belt
- Travel Requirements are up to 30%

## Responsibilities of the Sr. Engineer, Quality

The specific duties of the Sr. Engineer, Quality include but are not limited to:

- Confer with external and internal departments (example Product Development, Clinical, Marketing, Sales, and Operations) concerning product design to ensure user needs are met.
- Evaluate product design for manufacturability and suggest design process adjustments and quality improvements
- Engage in the selection, development, and qualification/validation of tools, fixtures, machinery, and equipment used in manufacturing
- Lead and participate in risk management activities.
- Lead Quality issue resolution by applying 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 in 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 for non-conformance reduction and inspection optimization
- Determines quality improvement parameters by identifying statistical methods relevant to manufacturing processes.
- Prepares reports and presentations by collecting, analyzing, and summarizing data; making recommendations.
- Maintains professional and technical knowledge by attending educational workshops; reviewing professional publications; establishing personal networks; benchmarking state-of-the-art practices; participating in professional societies;
- Collaborate with supply chain partners to assure quality of product.
- Confer with purchasing and logistics to maintain the supplier management program.
- Design and implement inspection methods, equipment, acceptance criteria and sampling plans.
- Initiate or assist in cost reductions of product inspections.
- Provide validation, sampling, and statistical analysis support to other functions in the organization.
- Perform First Article Inspections to ensure Manufacturing process capability.
- Ensure compliance with CGMP, QSR, ISO13485, MDD, and other applicable regulations/standards
- Participate in FDA inspections, ISO Certification, surveillance audits and customer audits
- Deploying proactive quality controls for consistent and predictable quality outcomes
- Establish and implement metrics for monitoring system effectiveness
- Report to management on quality issues, trends and losses
- Provide functional support as needed for all team members
- Direct staff as needed

Location

APC

## Benefits/Compensation

This position is eligible for an annual bonus.

Benefits offered for this position include Health, Dental, Vision, Matching 401K, Paid Time Off, 9 Paid Holidays + 3 Floating Holidays, Dependent Care Flexible Spending Accounts, Medical Flexible Spending Accounts, Tuition Reimbursement, Paid Parental Leave, Paid Caregiver Leave, Basic Life Insurance, Supplemental Life Insurance, Employee Stock Purchase Plan, and Disability Insurance, as described in more detail in summary plan descriptions.

Salary Range $84,190—$105,237 USD

Company Statements

Axogen follows healthcare system guidelines with respect to credentialing, vaccinations and other employment/compliance related requirements, as well as CDC guidance. Axogen reserves the right to amend its policies from time to time in its sole discretion.

As AI is becoming a common tool throughout the application process, we want to be clear about its appropriate use at Axogen. Using AI to support resume writing, research or interview preparation is perfectly acceptable, provided the content is accurate and genuinely represents your qualifications and skills. For other key parts of your interview process, however, it is important that the ideas, communication, and work you share reflect your own voice, experiences, and thinking. We ask that you participate in our live interviews and complete any assessments without AI assistance unless instructions explicitly indicate otherwise or a specific exception is discussed and approved in advance. This approach ensures fairness, celebrates your individuality, and allows your authentic perspective to shine. Behaviors that do not align with these guidelines may result in disqualification from the hiring process or termination of employment if later discovered. We appreciate your understanding and look forward to learning about the unique contributions only you can bring to Axogen.

No agency solicitation. We kindly request that recruiting agencies, staffing firms, and third‑party vendors do not contact us regarding this posting. Unsolicited résumés will not be considered.

## About Axogen

## Company Overview
- **One-liner**: Axogen is a medical technology company focused on the science, development, and commercialization of products for peripheral nerve regeneration and repair, aiming to make restoration of nerve function an expected standard of care.
- **Entity Type**: Public (NASDAQ: AXGN)
- **Headquarters**: Alachua, Florida, United States
- **Founded**: Not publicly available in provided sources
- **Founders**: Not publicly available in provided sources

## Core Business
- **Primary industry/industries**: Medical devices and biologics for peripheral nerve repair (surgical technologies)
- **Target customers**: B2B – hospitals, surgeons, and healthcare providers (orthopedic, plastic, neuro, and hand surgeons)
- **Mission statement**: “To restore health and improve quality of life by making restoration of peripheral nerve function an expected standard of care.” [axogeninc.com/about-axogen](https://www.axogeninc.com/about-axogen/)

## Products & Services
Axogen offers a comprehensive portfolio of implantable biologic and extracellular matrix products for peripheral nerve repair and protection:
- **Avance® (acellular nerve allograft)**: An FDA-approved scaffold for bridging nerve gaps; approved as a biologic (BLA) in December 2025 for sensory, mixed, and motor nerve discontinuities. [ir.axogeninc.com](https://ir.axogeninc.com/sec-filings/all-sec-filings/content/0000805928-26-000031/axgn-20251231.htm)
- **Avance® Nerve Graft**: A biologically active processed human nerve allograft for bridging severed peripheral nerves without a second surgical site (being transitioned to Avance under BLA).
- **Axoguard Nerve Connector®**: A porcine-derived extracellular matrix coaptation aid for tensionless repair of severed nerves.
- **Axoguard Nerve Protector®**: A wrap used to protect and reinforce damaged peripheral nerves.
- **Axoguard HA+ Nerve Protector™**: A next-generation product with a hyaluronate-alginate coating for enhanced gliding and protection.
- **Axoguard Nerve Cap®**: Designed to protect the nerve end and reduce symptomatic neuroma formation.
- **Avive+ Soft Tissue Matrix™**: A multi-layer amniotic membrane allograft for soft tissue separation and protection during healing.

All products are classified as surgical implants (HCT/P or biologic), used in operating rooms.

## Market Standing
- **Valuation/Market Cap**: Aggregate market value of non-affiliate held common equity was approximately **$430.7 million** as of June 30, 2025 (based on last reported sale price). [ir.axogeninc.com](https://ir.axogeninc.com/sec-filings/all-sec-filings/content/0000805928-26-000031/axgn-20251231.htm)
- **Key Metric**: Invested **$32.9 million in R&D** during fiscal year 2025; **138 direct sales professionals** in the U.S. as of December 31, 2025.
- **Notable Investors/Partners**: Not publicly disclosed in provided materials. The company participates in major industry conferences (e.g., 2026 Bank of America Global Healthcare Conference). [ir.axogeninc.com](https://ir.axogeninc.com/)
- **Growth Signals**:
  - FDA Biologics License Application (BLA) approval for Avance in December 2025, unlocking a regulated biologic pathway and a new manufacturing facility in Vandalia, Ohio.
  - Significant reimbursement improvements: Medicare outpatient payment for nerve allograft repair increased 96% over 2019 (221% in ambulatory surgery centers).
  - Over 350 peer-reviewed clinical publications supporting product use.
  - Expanding sales force and hybrid agency model; international sales in Canada, Germany, UK, Spain, and other countries.

## Competitive Advantages
- **Single-focused leadership**: Axogen is the only company exclusively dedicated to peripheral nerve repair, with the most comprehensive portfolio on the market.
- **Regulatory moat**: First and only FDA-approved biologic (BLA) for nerve allograft (Avance), creating higher barriers to entry.
- **Strong clinical evidence**: >350 peer-reviewed studies and a robust post-market study requirement that will differentiate efficacy versus nerve autograft.
- **Favorable reimbursement**: Dedicated Category I CPT codes (64912/64913) and CMS payment enhancements reduce economic barriers for hospitals.
- **Established sales force**: Large direct team plus independent agencies covering remote geographies.

## Strategic Focus
- **Product commercialization**: Launch Avance under BLA in early Q2 2026 and complete the transition from the previous 361 HCT/P framework.
- **Confirmatory studies**: Fulfill FDA post-marketing requirement for Avance in mixed/motor nerve gaps (study due by 2030).
- **Sales expansion**: Increase sales force productivity and add new accounts, especially in underpenetrated markets (oral maxillofacial, breast reconstruction neurotization, urology).
- **International growth**: Expand geographic presence beyond current countries.
- **Manufacturing scale**: Utilize the new Vandalia, Ohio facility to support anticipated growth.

## Why Work Here
- **Mission-driven culture**: Employees are empowered by the “gift of human tissue” to restore nerve function and improve quality of life for patients. [axogeninc.com/about-axogen/careers](https://www.axogeninc.com/about-axogen/careers/)
- **Core values**: Think Like a Customer, Encourage Innovation and Risk-Taking, Embrace Collaboration, Never Forget Our Purpose, Lead by Example.
- **Work environment**: Headquarters in Alachua, Florida (near Gainesville); additional facilities in Vandalia, Ohio. Hybrid/office policy not explicitly stated but on-site presence likely for R&D, manufacturing, and sales support.
- **Engineering & scientific culture**: Heavy investment in R&D (over $32M/yr) and clinical research; opportunity to work on cutting-edge regenerative medicine products.
- **Growth trajectory**: Rapidly growing company with recent FDA approval and expanding commercial reach, offering career advancement potential.

## Sources
1. [axogeninc.com/careers - Culture and values](https://www.axogeninc.com/about-axogen/careers/)
2. [axogeninc.com - Company overview and mission](https://www.axogeninc.com/)
3. [axogeninc.com/about-axogen - Leadership and commitment](https://www.axogeninc.com/about-axogen/)
4. [ir.axogeninc.com - Investor relations, financials, and press releases](https://ir.axogeninc.com/)
5. [ir.axogeninc.com - 10-K Annual Report for FY2025](https://ir.axogeninc.com/sec-filings/all-sec-filings/content/0000805928-26-000031/axgn-20251231.htm)

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