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 IT Business Analyst
A skilled and detail-oriented IT Business Analyst is needed to analyze, document, and maintain end-to-end change control processes within our Change Control system. This role will serve as a critical bridge between business stakeholders and technical teams, ensuring accurate documentation, effective requirement gathering, and the successful implementation of system enhancements. The ideal candidate will bring a strong combination of analytical skills, technical expertise, and experience in regulated environments to deliver high-quality solutions that align with Axogen’s compliance requirements and operational goals.
Requirements of the IT Business Analyst
- Bachelor’s degree in information systems, Computer Science, Engineering, or related field.
- Minimum 2 years of experience as a Technical Analyst, Business Analyst, or similar role.
- Strong experience in change control processes within regulated environments (medical device, pharma, biotech).
- Proven ability to gather and document detailed business and technical requirements.
- Familiarity with SDLC, Agile, or hybrid methodologies.
- Experience working in GxP-regulated environments.
Preferred Qualifications
- Experience in medical device industry (highly desirable for Axogen environment).
- Knowledge of FDA 21 CFR Part 11, ISO 13485, and related compliance standards.
- Experience with system integrations, APIs, or data mapping.
- Exposure to validation documentation and computer system validation (CSV) processes.
- Hands-on experience with Regulated Change Control System like Master Control
Key Skills
- Strong analytical and problem-solving abilities
- Excellent written and verbal communication skills
- Process mapping and documentation expertise
- Attention to detail and compliance mindset
- Ability to manage multiple priorities in a fast-paced environment
- Collaboration and stakeholder management
Soft Skills
- Excellent problem-solving and analytical abilities with process improvement mindset
- Strong communication skills to explain AI and automation concepts to non-technical stakeholders
- Collaborative mindset with cross-functional team experience
- Self-motivated with ability to manage multiple priorities
- Passion for continuous learning in AI and automation advancements
- Business acumen to identify and quantify automation opportunities
Responsibilities of the IT Business Analyst
The specific duties of the IT Business Analyst Engineer include but are not limited to:
Change Control Documentation
- Analyze, document, and maintain end-to-end change control processes within Change Control System.
- Ensure all documentation aligns with compliance requirements.
- Identify opportunities to optimize and standardize change control workflows
Business Requirements Gathering
- Collaborate with internal business stakeholders to gather, analyze, and validate requirements.
- Conduct workshops, interviews, and process reviews to understand current-state and future-state needs.
- Translate business requirements into functional and technical specifications.
- Create clear artifacts such as BRDs, FRDs, user stories, and process flow diagrams.
Technical Analysis & Development Support
- Work closely with development and configuration teams to translate requirements into technical design.
- Provide detailed system configuration guidance for integrated platforms.
- Support solution design discussions, ensuring feasibility and scalability.
- Assist with system integrations, data mapping, and interface specifications where applicable.
Testing & Implementation
- Coordinate and support User Acceptance Testing (UAT) with business users.
- Ensure traceability from requirements through testing and deployment.
Stakeholder Communication & Support
- Act as the main liaison between business users, IT teams, and vendors.
- Provide regular updates on project progress, risks, and deliverables.
- Support training efforts and knowledge transfer for system users.
Location
111 West Oak Ave., Tampa, FL 33602
#LI-AC1
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.
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.