Engineer II, Manufacturing & Processing

Axogen, Inc.; Vandalia (OH); On-site; USD 69,000 - 87,000; Full time

Benefits offered by this job

Health

Dental

Vision

Matching 401K

Paid Time Off

Paid Holidays

Floating Holidays

Dependant Care FSA

Medical FSA

Tuition Reimbursement

Paid Parental Leave

Paid Caregiver Leave

Basic Life Insurance

Supplemental Life Insurance

Employee Stock Purchase Plan

Disability Insurance

Job summary

Axogen, Inc. is hiring an Engineer II for Manufacturing/Processing in Dayton, OH. The role provides engineering and production support to ensure compliant manufacturing of medical products, while collaborating with R&D and QA to drive continuous improvement and timely product releases.

This position requires a BS in Engineering or related field (MS preferred), 2–4 years in a regulated environment, and hands-on technical skills. Strong ability to work with limited supervision is expected.

Qualifications

• Bachelors in Engineering or related field; Graduate degree preferred.
• Two to four years' experience as an engineer in a regulated industry.
• Experience in tissue engineering and regenerative medicine products is a plus (cleanroom processing, aseptic technique, tissue preservation, AATB standards).
• Demonstrated hands-on technical skills.
• Ability to work with limited supervision.

Responsibilities

• Supports Production on a day-to-day basis and ensures product is released in a timely manner.
• Reprioritizes tasks as the needs of the company change.
• Provides focused technical/engineering support to Operations on manufacturing projects with emphasis on capacity analysis, yield improvements, cost reduction, validations, implementing processes for new products and improvements.
• Supports and collaborates with R&D and Quality Management on new product launches.
• Analyzes product and/or equipment specs to determine feasibility of new plant equipment or modifications.
• Leads continuous improvement projects.
• Provides expertise and technical communications on quality issues.
• Provides cross-functional project management support to other areas of the business.
• Uses root cause analysis and statistics to resolve processing issues.
• Complies with all company policies and SOPs.

Skills

Bachelor's in Engineering

Regulated industry experience

Tissue engineering

Hands-on technical skills

Independent work

Education

Bachelor's Degree in Engineering or related discipline

Graduate degree preferred

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 Engineer II, Manufacturing & Processing

The Engineer II, Manufacturing/Processing Engineer position located in Dayton, OH will provide engineering and production support for Manufacturing Operations and New Product Development Teams to ensure new/improved and current medical products and processes are being produced in compliance with applicable standards and regulations.

Requirements of the Engineer II, Manufacturing & Processing

• Bachelor's Degree in Engineering or related discipline (Graduate degree preferred)
• Preferred education focus in biomedical engineering, chemistry or biological sciences
• Two to four years' experience in working as engineer in regulated industry
• Experience in tissue engineering and regenerative medicine products a plus (cleanroom processing, aseptic technique, tissue preservation, AATB standards)
• Demonstrated hands on technical skills
• Ability to work with limited supervision

Responsibilities of the Engineer II, Manufacturing & Processing

• Supports Production on a day-to-day basis and ensures product is being released in a timely manner
• Reprioritizes tasks as the needs of the company change
• Provides focused technical/engineer support to Operations on manufacturing projects with an emphasis on capacity analysis, yield improvements, cost reduction, validations, implementing processes associated with new products and process improvements
• Supports and collaborates with Research and Development and Quality Management on new product launches
• Analyzes product and/or equipment specifications and performance requirements to determine feasibility of new plant equipment, or modifying existing equipment
• Leads continuous improvement projects
• Provides expertise and technical communications on quality issues
• Provides cross-functional project management support to other areas of the business
• Utilizes root cause analysis methods and statistical tools to resolve processing issues
• Complies with all company policies, procedures, and SOP's

Location

913 Industrial Drive Place, Vandalia, OH 45377 #LI-AC1

Benefits/Compensation

• 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
• Disability Insurance
• as described in more detail in summary plan descriptions.
• This position is eligible for an annual bonus.

Salary Range$69,333 - $86,666 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.