Operator IV - 2nd Shift

Job Type

Full-time

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.