Axogen
Sr.Engineer,Manufacturing/Processing
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“Sr. Engineer, Manufacturing/Processing at Axogen. Skills: Manufacturing Engineering, Process Design, Project Leadership. Support production to maintain inventory flow. Address issues quickly and effectively”
What You'll Achieve.
Restore health and improve quality of life; Make restoration of peripheral nerve function an expected standard of care; Lead the markets we serve; Provide improved benefit-to-risk profile; Deliver improved benefit-to-risk solutions; Target advancements in standards of care; Maintain inventory flow and levels to meet demand; Address issues quickly and effectively; Execute complex cross functional projects; Improve productivity; Improve quality; Improve cost; Improve cycle time; Improve yield; Maintain and improve quality of existing operations; Develop and implement associated processes; Determine feasibility of new plant equipment; Resolve processing issues; Determine in-control/out-of-control; Inspect, test and evaluation of products for acceptability; Execute equipment installation and operational qualifications; Execute process validations; Maintain calibration program
Industry & Context.
Root cause analysis; Statistical tools; Statistical methods
Travel up to 20%, Verbal communication, Typing, Standing, Sitting, Walking, Pushing, Pulling, Stooping, Seeing, Process and handle human and animal tissue based products
What They're Looking For.
Must Have
Bachelors degree in Engineering or related science, 5 years of experience, Medical device, biologic or HCTP experience, 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, Oral & written communications skills, Computer software skills including but not limited to: MS Office, database, Excel, and MS Project, Willingness to process and handle human and animal tissue based products
Nice to Have
Lean manufacturing and/or process controls experience a plus
What You'll Do.
Support production to maintain inventory flow
Address issues quickly and effectively
and execute complex cross functional projects
Lead continuous improvements activities
Maintain and improve quality of operations
Represent operations on new product development
Develop and implement associated processes
Analyze product or equipment specifications
Develop and implement inspection methods
Develop and execute equipment installation
Develop and execute process validations
Develop and maintain support systems
Support integration of new business processes
Maintain calibration program
How You'll Work.
Team & Collaboration
Cross functional projects impacting operations; Represents operations on new product development
Communication Scope
Oral communication; Written communication; Technical communications
Process & Methodology
Project leadership, Project management, Complex cross functional projects
Full 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, Manufacturing/Processing 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 the Sr. Engineer, Manufacturi
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