ChoiceSpine is a privately held medical device 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. ChoiceSpine has been named a Top Knoxville Workplace for three 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.

As a member of the Logistics team, you will be assisting in the incoming and outgoing distribution of products to our customers. This position requires a detail-oriented candidate with the ability to multi-task while communicating and following up with the team.

ESSENTIAL DUTIES ADN RESPONSIBILITIES

• Receive surgical sets and associated field Inventory from hospital and distributors.
• Wash instrumentation as per ChoiceSpine procedures.
• Reconcile and replenish sets as per the Bill of Materials.
• Ensure set instrumentation and implants function properly and are aesthetically presentable.
• Utilize labeling software to fulfill internal labeling/re-labeling requirements.
• Perform cycle counts and reconcile discrepancies.
• Pull, audit, pack and ship orders using FedEx and UPS.
• Follow housekeeping procedures which include but are not limited to; keeping personal workstation clean and organized; returning tools to proper locations; and organizing storage areas.
• Follows departmental safety policies and procedures and reports safety issues and concerns immediately.
• The responsibilities listed are a general overview of the position and additional duties may be assigned.
• Shift hours are 10:00 to 7:00 EST.

SUPERVISORY RESPONSIBILITES

Not applicable

QUALIFICATIONS

The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform essential functions.

• Excellent organization skills and meticulous attention to detail
• Excellent communication skills, both verbal and written
• Basic computer skills required (Word, Excel, Outlook)
• Must have excellent problem-solving skills
• Ability to work collaboratively with team
• Experience in Sterile Processing is a plus

EDUCATION and EXPERIENCE

High school diploma or equivalent and experience in warehouse or hospital environment preferred.

EXEMPTION

Non-Exempt

PHYSICAL DEMANDS 

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the 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 handle or feel; and reach with hands and arms. The employee must occasionally lift and/or move up to 50 pounds with help if needed. Must be able to visually inspect small parts.

WORK ENVIRONMENT 

The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

Working environment is typical of an office, manufacturing, and laboratory environment. Working in this environment may require the use of safety equipment, including but not limited to eye safety glasses, hearing protectors, and gloves.

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.