Operator IV (Active Implantable) at RESOLUTION MEDICAL LLC

Minneapolis, Minnesota, United States -

Full Time

Start Date

Immediate

Expiry Date

14 Apr, 26

Salary

31.0

Posted On

14 Jan, 26

Experience

10 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Medical Device Assembly, Manufacturing Experience, Good Manufacturing Practices, Measurement Equipment, Critical Reasoning Skills, Small Scale Assembly, Circuit Board Soldering, Laser Welding, Hermetic Laser Welding, Neuromodulation Lead Assembly, Problem Solving, Manual Dexterity, Hand-Eye Coordination, Confidential Information Handling, Flexibility, Stress Management

Industry

Medical Device

Description

Description Job Summary The Operator IV role will be responsible for conducting complex builds of long term active implantable Class 3 devices, technical support for R&D programs, testing of product, and product development activities. 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 medical device 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 performing small scale assembly work under a microscope in a clean room and ESD controlled environment Experience with circuit board soldering, laser and resistance weld assembly, and hermetic laser welding. Experience with IPG header assemblies (epoxy potting and pre-molded bonding using medical adhesives and epoxies). Experience with neuromodulation lead assembly/processing (cable to electrode welding, molding, centerless grinding, RF bonding, and testing. 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.

Responsibilities

The Operator IV will conduct complex builds of long-term active implantable Class 3 devices and provide technical support for R&D programs. They will also be responsible for testing products and participating in product development activities.