INGENYX- Suture Assembly Technician

Position Summary

The Suture Assembly technician position utilizes established documentation, assembly techniques, equipment, quality systems, and production processes in accordance with safety procedures, medical device regulations, and Good Manufacturing Practices (GMP) to manufacture suture products and advanced suture assemblies. Primary responsibilities include manual threading of loops, specialty assemblies, inspection, and finishing operations requiring precision hand-eye coordination and fine motor skills. This position may also support fiber winding, braiding, and other manufacturing operations as needed.

Principal Responsibilities

•    Perform manual assembly of sutures, threaded loops, specialty assemblies, and other customer-specific products according to approved work instructions and specifications.
•    Thread sutures through loops, components, and assemblies utilizing magnification devices and specialized assembly fixtures as required.
•    Conduct visual inspections throughout the assembly process to ensure conformance to product specifications and quality standards.
•    Understands and uses various measuring equipment such as calipers, micrometers, rulers, Instron, and other inspection equipment as required.
•    Accurately complete production records, batch documentation, and quality documentation in accordance with GMP requirements.
•    Maintain traceability and product identification throughout the manufacturing process.
•    Follow applicable safety requirements, procedures, work instructions, and standards as required, including use of personal protective equipment.
•    Support production operations, including bobbin winding, braiding, cutting, packaging, labeling, and related manufacturing activities as trained and assigned. 
•    Use personal judgement in problem solving and troubleshooting problems.
•    Maintain organized and clean work areas in accordance with 5S and company standards.
•    Work flexible hours as required to support business needs.
•    Maintain compliance with clean room requirements by following gowning procedures, contamination control practices, environmental protocols, and material handling requirements to ensure product quality and regulatory compliance

Education / Experience Requirements

•    Minimum of High School diploma or GED from an accredited institution required.
•    Medical device manufacturing experience preferred.
•    Experience performing detailed hand assembly, precision manufacturing, textile assembly, or similar work highly preferred.

Specialized Skills / Other Requirements

•    Ability to perform repetitive, detailed assembly operations with a high degree of accuracy 
•    Stong interpersonal, communication and documentation skills.
•    Strong attention to detail
•    Strong hand-eye coordination
•    Ability to work with small components, threads, fibers, and assemblies
•    Basic math skills including addition, subtraction, multiplication, and division.
•    Verbal communication skils including demonstrated ability to read, write, and speak English fluently
•    High degree of initiative and accountability
•    Ability to work independently with minimal supervision 
•    Basic computer skills including Microsoft Office.
•    Fine motor skills required for threading, knotting, looping, and precision assembly operations 
•    Consistent lifting/pulling: 2-20 lbs. necessary/ Max = 30 pounds
•    Must be able to reach, grasp, pull push consistently, Repetative Motion
•    Fine motor skills required
•    Sight: Vision must be strong enough, with or without corrective lenses, to allow employee to safely and accurately complete their job responsibilities

The pay range for this position at commencement of employment is expected to be between $25-43 per hour, however, base pay offered may vary depending on multiple individualized factors, including market location, job-related knowledge, skills, and experience.  The total compensation package for this position will also include benefits such as medical, prescription drug, dental and vision insurance, flexible spending accounts, participation in 401(k) savings plan, and various paid time off benefits, such as PTO, short- and long-term disability and parental leave, dependent on the position offered. Details of participation in these benefit plans will be provided if an employee receives an offer of employment.
 
If hired, employee will be in an “at-will position” and the Company reserves the right to modify base salary (as well as any other discretionary payment or compensation program) at any time, including for reasons related to individual performance, Company or individual department/team performance, and market factors.