Operator III - Medical Device

DescriptionJob SummaryThe Operator III role will be responsible for conducting general manufacturing operations, technical support for R&D programs, testing of product, and product development activities.Essential FunctionsWork with project team, Line Lead, or Supervisor to ensure customer demand and the production schedules are metRead work orders, follow production drawings and sample assemblies, receives verbal instructions regarding duties to be performed, and complete necessary SWO’s or work orders as requiredReport problems or concerns with quality, processes, equipment, materials, or labor the supporting engineer, project team, lead, or supervisorAccurately complete all essential documents (i.e., Lab Notebooks, DeviceMaster Records (DMR’s), Lot History Records (LHR’s), Inspection Records and Validation DocumentationProvide training to new team members and provide cross-training for current team membersRecord observations of both assembly processes and assembly (or component) performanceIdentify opportunities for productivity and quality improvementsEnsure equipment is maintained and calibrated within defined timelines, when possible, in order to minimize interruption to production linesAdjusts and trims materials from components to achieve specified medical or dimensional characteristicsMaintain a clean, safe, and organized work environmentSupport company finance, accounting, human resources, quality, regulatory, and clinical departments as necessary to ensure compliance with requirements.RequirementsEducation, Experience, Required SkillsHigh school graduate or GED equivalent5+ years of assembly and/or manufacturing experience with increasing complexity3+ years of experience of experience building catheters (complex delivery systems, etc.)Demonstrated ability to read and understand measurement equipment (e.g., caliper, ruler, micrometer, microscope)Working knowledge of Good Manufacturing Practices (GMP)Ability to work independently with little oversightAccurately read work orders, following production drawings, and receive instructionAccurately complete all essential documents (Lab Notebooks, Device Master Records, Lot History Records, Inspection Records, and Validation Documentation)Experience and/or training in using a microscope in assembly, working with different types of catheter materials, or other similar medical devices with small partsAbility to handle and be trusted with confidential and/or sensitive information.Able to work in a fast-paced, constantly changing environment.Ability to be flexible and to handle multiple projects in an organized, timely manner.Able to problem-solve, work under pressure, and to effectively manage stress.Ability to work overtime as neededPhysical RequirementsProlonged periods of sitting at a desk and working on a computer and/or microscopeProlonged periods of standing and/or walkingMust be able to lift up to 25 pounds at timesManual dexterity in order to assemble products or machines as directedExcellent hand-eye coordinationAbility to differentiate between colored wires, tabs, and electronic componentsMust wear gown, gloves, and ear protection when applicableMust be willing to work in lab and clean room environments to support project workSummary Of BenefitsGroup health & welfare benefits: Options for Medical, Dental and Vision insurance, Health Savings Account (requires participation in eligible medical plan), and Flexible Spending Accounts.Company-paid benefits: Employee Life Insurance & Accidental Death & Dismemberment (AD&D), Long Term Disability (LTD), Kavira (requires participation in medical plan).Voluntary, employee-paid benefits: Employee Supplemental Life & AD&D, Spouse and Dependent Life & AD&D, Short Term Disability (STD), Accident, Critical Illness, and Hospital Indemnity, Employee Assistance Program.Accrued Paid Time Off (PTO) & Floating HolidaysPaid Parental LeavePaid HolidaysBenefits and incentive compensation may be subject to generally applicable eligibility, waiting period, contribution, and other requirements and conditions.CompensationThe typical base pay range for this role is between $22.00-24.00/hour. Compensation may vary based on individual job-related knowledge, skills, expertise, and experience. This position is eligible for a discretionary annual incentive program driven by organization and individual performance.401(k) Plan: Company-provided Safe Harbor Contribution of 3% of eligible earnings.