Choice Spine is a privately-held company based in Knoxville, TN, and a leading designer, manufacturer, and distributor of specialized spinal implants, instrumentation, and biologics for the surgical treatment of complex spinal disorders. Choice Spine has been named a Top Knoxville Workplace for two consecutive years. We offer a competitive salary, comprehensive benefits (including company-paid Life/STD/LTD), 401(k), paid vacation and holidays, and an excellent work environment.

SUMMARY
Under routine guidance, primarily responsible for designing and developing new spinal products/product families and/or enhancing existing products. Involved in creating designs, modeling, and drafting, utilizing a 3D CAD system. Other responsibilities include assisting in the development process with Marketing, Purchasing, Manufacturing, Quality, and Regulatory to help complete delegated tasks from project conceptualization through full market launch.

PRIMARY RESPONSIBILITIES

• Research, develop, and design spinal implants & instruments following FDA and ISO requirements. New Product Development as well as maintenance of existing legacy systems.
• Support identification and timely execution of product development process and project deliverables, including concept design, testing, design finalization, verification/validation activities, transfer, and launch support.
• Execute development activities of complex line extensions and special instrument modifications in an abbreviated schedule with the assistance of Senior Engineering Staff.
• Create designs using CAD (SolidWorks) for subtractive and additive manufacturing methods. Generate 3D part files, 3D assembly files, & 2D technical drawings.
• Write protocols, execute, analyze test data, and generate reports to verify or validate that designs meet functional and performance specifications, including interactions with outside testing facilities.
• Generates and manages the Change Order process for initial release & revision of device-related changes, including potential impacts on current design inputs, risk, and relevant controlled documents in the system Design History File.
• Competent interface with ALL customers (Surgeons, Distributors, FDA, Manufacturers, Consultants, Etc.) to discuss design inputs, functional instruction, and current challenges for new product development and legacy systems.Collaborate with senior engineering and cross-functional departments to identify and ensure project team and senior management are a
• Aware of upcoming milestones and risks/issues.
• Utilize in-house rapid prototyping and interface with suppliers to provide support during the manufacturing process.
• Review and approve product Inspection Standards, overlays, and gauges in collaboration with the Quality department.
• Comfortably provide technical assistance to other areas of the organization including, but not limited to, Sales, Marketing, Quality, Regulatory, Purchasing, Sales Support and Executive Management.
• Conduct static and fatigue stress analysis on developed designs using FEA, including interpretation of results.
• Collaborate & offer background, knowledge, & expertise with other Group staff.
• Follow organizational & group guidelines, procedures, and protocols.
• Assist senior engineering staff and patent counsel in preparing invention records and assisting in the patent submission process.
• Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties, or responsibilities required of the employee for this job. Duties, responsibilities, and activities may change at any time, with or without notice.

QUALIFICATIONS

• Proficiency with CAD software required (SolidWorks preferred).
• Working knowledge & experience with product development cycle and phased/gate approach of small projects.
• Familiarity with general manufacturing processes and common materials used to produce medical implants and instruments. Familiarity with Additive Manufacturing preferred.
• Experience with GD&T, stack-up analysis, and mechanical testing preferred.
• Exposure and familiarity with relevant ASTM, ISO, and FDA standards, regulations, and guidelines.
• Comfortable with the autonomy of responsibility in addition to a team environment.
• Be adept and flexible in managing multiple tasks at once while keeping to the set schedule of each task.
• Capable of presenting and sharing information with management, surgeons, and/or field personnel when requested (PowerPoint skills preferred).
• Ability to read, write, and interpret technical documents such as engineering drawings, regulations, company policies, and procedures.
• Competent in basic science and engineering principles, including physics, algebra, and statistics, with the ability to understand and solve technical problems, collect and analyze data, draw valid conclusions, and communicate findings.
• Familiarity with Project Management planning preferred (MS Project, Smartsheet, etc.)
• Experience in identifying and investigating issues, proposals of appropriate solutions, and implementation aid to resolve the problem.

EDUCATION and EXPERIENCE

• BS in Mechanical Engineering or Biomedical Engineering or equivalent
• 3-6 years of experience preferred.
• Product development experience preferred.
• Spinal or Orthopedic Implant design experience preferred.

PHYSICAL DEMANDS 

• The physical demands described here represent those that an employee must meet to perform the essential functions of this job successfully. Reasonable accommodations may be made to enable individuals with disabilities to perform essential functions.
• While performing the duties of this job, the employee is regularly required to sit and talk or hear. The employee is occasionally required to stand, walk, use hands to finger, handle, or feel and reach with hands and arms. The employee must occasionally lift and/or move up to 25 pounds.

WORK ENVIRONMENT 

• The work environment characteristics described here represent those employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform essential functions.
• The working environment is typical of an office environment. The noise level in the work environment is usually moderate.

SUMMARY

Under supervision from the Quality Manager, the Associate Quality Engineer will support Engineering and Quality Assurance activities and assist Quality Control and Regulatory as part of a comprehensive Quality Management System.

ESSENTIAL DUTIES AND RESPONSIBILITIES

• Read, understand, and interpret engineering drawings and associated GD&T
• Perform transactions in ERP system as necessary
• Identify non-conforming product and generate non-conformance reports as needed.
• Read and conform to all company policies and procedures
• Interact and communicate with internal departments, including Purchasing, Shipping / Receiving, Engineering, Customer Service, and Sales / Marketing
• Create non-conformance reports for non-conforming product
• Authority to place product on hold
• Involved with new product development (NPD) process and the support of existing and previously commercialized products.
• Review and approve engineering drawings and assist in determining Critical-To-Quality Dimensions.
• Create, Review, and Approve Inspection Plans and Inspection tools as required.
• Create and Support validations for new and existing products and processes, including packaging and sterilization.
• Create and Support IQ, OQ, and PQ activities for equipment and additive implants.
• Perform and support Gage Repeatability and Reproducibility (Gage R & R) studies
• Perform and support First Article Inspection / Inspections on Prototypes
• Perform Statistical rationales as required
• Support supplier quality management activities, including qualification, evaluation, and investigations
• Support Post Market Surveillance activities
• Support Complaint/NC/CAPA teams through the identification and development of corrective action plans, verification, and closure
• Perform and support Design and Process FMEA activities
• Collect, analyze, and summarize data and make recommendations as required
• Support and prepare for site-level internal, external, supplier, and customer audits
• Provide quality support to identify and resolve quality issues to ensure safe and effective medical devices
• Interact and coordinate activities with other departments, support, and customers
• Identify and implement opportunities for continuous improvement.
• Create and update Quality System Procedures and Instructions when applicable.
• Supports Operations when Engineering changes occur
• Supports Quality, Engineering, and Regulatory to meet company and department objectives
• Other duties as assigned by management

SUPERVISORY RESPONSIBILITIES

Not Applicable

QUALIFICATIONS

• Excellent communication skills and the ability to work with people at all levels
• Ability to work independently and in a team environment.
• Strong organization skills, attention to detail, self-motivator, ability to multi-task and meet timelines
• Working knowledge of desktop computer office software and e-mail is required.
• Understand calibration fundamentals
• Experience using inspection equipment such as calipers, micrometers, height gauges, plug and ring thread gauges, and pin gauges. Optical comparator and Vision system experience preferred
• Understanding of SOLIDWORKS or 3D modeling is preferred
• Knowledge and understanding of Medical Device Regulations / Certifications such as 21CFR820 & ISO13485:2016
• Medical Device experience is required

EDUCATION and EXPERIENCE

Engineering / Science degree or equivalent and up to 4 years experience with mechanical inspection of precision machined products, medical device industry experience preferred.

CERTIFICATES, LICENSES, REGISTRATIONS

Not Applicable

EXEMPTION

Exempt

PHYSICAL DEMANDS 

The physical demands described here represent those that an employee must meet to perform the essential functions of this job successfully. Reasonable accommodations may be made to enable individuals with disabilities to perform essential functions.

While performing the duties of this job, the employee is regularly required to sit and talk or hear. In addition, the employee should be able to stand, walk, use hands to finger, handle, or feel and reach with hands and arms. In addition, the employee must occasionally lift and move up to 25 pounds. 

WORK ENVIRONMENT 

The work environment characteristics described here represent those an employee encounter while performing this job’s essential functions. Reasonable accommodations may be made to enable individuals with disabilities to perform essential functions. The working environment is typical of an office environment. The noise level in the work environment is usually moderate.