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.
