Operator IV - 2nd Shift (4 x 10 shifts M-TH)

Operator IV - 2nd Shift (4 x 10 shifts M-TH) Fridley, MN Job Details Full-time $24 - $31 an hour 9 hours ago Benefits Paid parental leave Health savings account AD&D insurance Paid holidays Disability insurance Health insurance Dental insurance 401(k) Flexible spending account Paid time off Parental leave Employee assistance program Vision insurance Life insurance Qualifications Mechanical assembly Maintaining an organized workspace Inspection tools Calibration New product development Regulatory compliance GMP Technical support Inspection reporting and documentation High school diploma or GED Dimensional measurements Microscope proficiency Quality control documentation Staff training Cleanroom Training & development Manufacturing Clean workspace maintenance Senior level Research & development Manufacturing company experience Measurement (quality control) 10 years

Full Job Description Description:

Job Summary The Operator IV role will be responsible for conducting complex NPI build/assembly operations, technical support for R D programs, testing of product, and product development activities.

Please note:

The schedule for this position is 3:30 pm - 2:00 AM, Monday - Thursday. Essential Functions Work with project team, Line Lead, or Supervisor to ensure customer demand and the production schedules are met Read work orders, follow production drawings and sample assemblies, receive verbal instructions regarding duties to be performed, and complete necessary SWO's or work orders as required Report problems or concerns with quality, processes, engineering, equipment, materials, or labor the supporting engineer, project team, lead, or supervisor Accurately complete all essential documents (i.e., Lab Notebooks, Device Master Records (DMR's), Lot History Records (LHR's), Inspection Records and Validation Documentation Provide training to new team members and provide cross-training for current team members Record observations of both assembly processes and assembly (or component) performance Identify opportunities for productivity and quality improvements Ensure equipment is maintained and calibrated within defined timelines, when possible, in order to minimize interruption to production lines Adjusts and trims materials from components to achieve specified medical or dimensional characteristics Maintain a clean, safe, and organized work environment Support company finance, accounting, human resources, quality, regulatory, and clinical departments as necessary to ensure compliance with requirements.

Requirements:

Education, Experience, Required Skills High school graduate or GED equivalent 10+ years of assembly and/or manufacturing experience with increasing complexity 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 oversight and apply critical reasoning skills Accurately read work orders, following production drawings, and receive instruction Accurately complete all essential documents (Lab Notebooks, Device Master Records, Lot History Records, Inspection Records, and Validation Documentation) Experience ausing a microscope in assembly, working with different types of catheter materials, or other similar medical devices with small parts Ability 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 needed Physical Requirements Prolonged periods of sitting at a desk and working on a computer and/or microscope Prolonged periods of standing and/or walking Must be able to lift up to 25 pounds at times Manual dexterity in order to assemble products or machines as directed Excellent hand-eye coordination Ability to differentiate between colored wires, tabs, and electronic components Must wear gown, gloves, and ear protection when applicable Must be willing to work in lab and clean room environments to support project work Summary of Benefits Group 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 Holidays Paid Parental Leave Paid Holidays Benefits and incentive compensation may be subject to generally applicable eligibility, waiting period, contribution, and other requirements and conditions. Compensation The typical base pay range for this role is between $24.00-31.00/hour. This position is eligible for a shift differential of $1.00/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.