axogen · 17 hours ago
Sr. Engineer, Systems Integration (Quality Control)
Vandalia, OH
Full-time
Onsite
Senior Level
$84K/yr - $105K/yr
5+ years expAxogen is committed to restoring health and improving quality of life through innovative solutions in peripheral nerve function. The Sr. Engineer, Systems Integration will drive continuous improvement and digital transformation in a regulated pharmaceutical manufacturing environment, utilizing Lean methodologies and stakeholder engagement to deliver compliant solutions.
BiotechnologyMedicalMedical Device
Responsibilities
Plans, leads, and executes complex cross-functional projects that impact operations, manufacturing and broader business functions
Drives multiple initiatives to completion with internal teams, external partners, and process customers, ensuring alignment, accountability, and measurable outcomes
Supports operations and manufacturing goals by coordinating deliverables, timelines, and stakeholder engagement across functions
Leads the implementation of automated processes—including development, equipment/process validations, specification creation, and cross-functional training
Supports the validation lifecycle for new and modified automations, ensuring regulatory compliance and performance readiness
Develops and sustains support systems for production workflows, enabling consistency, usability, and continuous improvement
Facilitates integration of new business processes into existing operational frameworks, bridging technical requirements with scalable solutions
Facilitates a consistent design methodology and standards for frontline process automations
Partners with MES vendor engineering team(s) to scope and co-develop platform features that address real-world operational challenges
Research device and system integrations, identifying optimal strategies for connecting equipment and systems to the MES platform
Conducts interviews, data collection, and research to generate actionable insights for solution design and deployment
Executes software validations and qualifications within respective departments
Designs and implements inspection, testing, and evaluation procedures to ensure product acceptability and regulatory alignment
Ensures all solutions and processes comply with strategic direction, quality standards, and regulatory requirements
Qualification
Required
Bachelor's degree in engineering or related science discipline with 5+ years' related experience OR Master's Degree in engineering or related science discipline and 2+ years' related experience
A Minimum of 2 years' experience in a Quality Control Lab, manufacturing, process design engineering, process optimization, or process development, within a GXP regulated environment (medical device, biologics, or pharmaceutical)
Willingness to handle human/animal tissue-based products
Travel up to 20% may be required
Strong understanding of Lean manufacturing, process validation, and compliance frameworks
Experience leading cross-functional teams and managing complex projects from concept to deployment
Excellent communication and stakeholder management skills across technical and non-technical audiences
Familiarity with IT/OT architecture, IoT applications, and system integration strategies
Proficiency in Excel, data analysis, and structured problem-solving methodologies
Preferred
Advanced Smartsheet proficiency
Current understanding of Axogen processes
Strong technical writing and presentation skills
Experience with SQL, Python, Power BI, and RESTful APIs a plus
Lean Six Sigma certification, value stream mapping, and process controls experience all preferred
Hands-on experience with Tulip, automation or similar low-code platforms preferred
Benefits
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
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
Company
axogen
AxoGen is a biotech company developing treatment options for the reconstruction and repair of peripheral nerve injuries.
201-500 employees
H1B Sponsorship
axogen has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2024 (1)
2020 (1)
Funding
Current Stage
Public CompanyTotal Funding
$255.92MKey Investors
PDL Biopharma
2026-01-23Post Ipo Equity· $124M
2017-11-15Post Ipo Equity· $41M
2015-08-28Post Ipo Equity· $17.5M
Leadership Team
Michael Dale
President and Chief Executive Officer
Marc Began
Executive Vice President, General Counsel
Recent News
legacy.thefly.com
2026-01-23
2026-01-22
2026-01-22
Company data provided by crunchbase