Sr. Manufacturing/Process Engineer

Axogen Alachua , FL 32615

Posted 2 weeks ago

Axogen is committed to building and maintaining a strong and gratifying company culture that fosters a work-life balance and 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 the leading company revolutionizing the science of nerve repair. We are passionate about helping to restore function and quality of life to patients with physical damage or discontinuity to peripheral nerves.

Contribute to positively impacting lives while working for a company that respects, recognizes, and values all team members!

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

  • Flexible working hours

  • Paid holidays, including floating holidays, to be used at your discretion

  • Employee Stock Purchase Plan

  • Referral incentive program

If you want to see how you can impact lives at Axogen, take a look at these inspiring patient stories:

Axogen is hiring for a Sr. Manufacturing/Process Engineer in Alachua or Tampa, FL!

Job Summary of Sr. Manufacturing/Process Engineer

The Sr. Manufacturing / Process Engineer will provide focused project leadership and technical support to Operations with an emphasis on project management, equipment qualification, standard operating procedures, standard costing, capacity analysis, yield improvements, cost reduction, planning, validations and metrology.

Requirements of Sr Manufacturing/Process Engineer

  • Bachelor's degree in Engineering or related science with 5 years' experience.

  • Medical device, biologic or HCTP experience required.

  • A minimum of 5 years experience in Manufacturing Engineering, Process Design Engineering, Process Optimization, or Process Development preferably with a regulated medical product.

  • Proven project leadership / management skills required.

  • Oral & written communications skills,

  • Computer software skills including but not limited to: MS Office, database, Excel, and MS Project

  • Lean manufacturing and/or process controls experience a plus.

  • Willingness to process and handle human and animal tissue based products,

  • Includes but is not limited to: verbal communication, typing, standing, sitting, walking, pushing, pulling, stooping, and seeing.

  • Position will require travel up to 20%

Responsibilities of Sr Manufacturing/Process Engineer

  • Supports production to maintain inventory flow and levels to meet demand

  • Addresses issues (e.g. NCR, CAPA) quickly and effectively

  • Plans, leads, and executes complex cross functional projects impacting operations and other areas of the business

  • Leads continuous improvements activities of productivity, quality, cost, cycle time and yield of raw material

  • Leads efforts to maintain and improve quality of existing operations, processes, and products

  • Represents operations on new product development teams. Develops and implements associated processes.

  • Analyzes product or equipment specifications and performance requirements to determine feasibility of new plant equipment or modifying existing equipment

  • May include reporting duties for multiple interns and/or engineers

  • Analysis and recommendations for capital equipment investments

  • Being a focal point for technical communications on quality issues

  • Utilizing root cause analysis methods and statistical tools to resolve processing issues.

  • Using statistical methods to determine in-control/out-of-control processes.

  • Developing and implementing methods and procedures for inspecting, testing and evaluation of products for acceptability

  • Leads the development and execution of equipment installation and operational qualifications.

  • Leads in the development and execution of process validations.

  • Leads in developing and maintaining support systems for production work processes

  • Supporting integration of new business work processes

  • Maintenance of the calibration program


1363 Progress Blvd., Suite 400

Alachua, FL 32615


111 West Oak Ave., 5th Floor

Tampa, FL, 33602


Axogen is on a hybrid work schedule at some facilities, with 3 days in office and 2 days remote.

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.

If you know someone who would be a great candidate for this position, or any others, just copy and send this link!

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Sr. Manufacturing/Process Engineer