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Principal Manufacturing Technician

Resolution Medical, LLC

Fridley (MN)

On-site

USD 60,000 - 80,000

Full time

17 days ago

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Job summary

A leading company in the medical device sector seeks a Principal Manufacturing Technician to provide technical support for NPI and manufacturing operations. The role involves maintaining cleanroom integrity, troubleshooting equipment issues, and training staff, contributing to process improvements and adherence to quality standards.

Benefits

Medical, Dental and Vision insurance
401(k) Plan with Company contribution
Paid Time Off and Holidays
Employee Life Insurance and Long Term Disability
Flexible Spending Accounts

Qualifications

  • 10+ years catheter experience in medical device manufacturing.
  • Prior experience in a regulated industry preferred.
  • Strong understanding of ISO 13485 quality standards.

Responsibilities

  • Troubleshoot process and equipment problems to minimize downtime.
  • Perform equipment setup and maintenance tasks.
  • Train and provide support to product builders and technicians.

Skills

Manual dexterity
Mechanical aptitude
Process improvement
Teamwork
Attention to detail
Problem-solving
Communication skills
Ability to handle confidential information

Education

High School Diploma or GED
2-year technical degree in a related course

Tools

3D CAD
RF tipping equipment
Reflow ovens
Vertical laminators
Laser bonders
UV curing equipment
Adhesive dispensers

Job description

Description

Job Summary

This position provides technical support for NPI and manufacturing cleanroom operations and projects. The Principal Manufacturing Technician is responsible for maintaining the integrity of the cleanroom manufacturing area, including test equipment, manufacturing machines, and ancillary equipment. This position includes different roles that focus on various procedures throughout the manufacturing process.

Essential Functions

  • Identify and troubleshoot process, material, or equipment problems to minimize downtime
  • Function as the first point of contact for lines support issues.
  • Identifies and implements corrective actions for manufacturing related issues.
  • Perform equipment setup and corrective, preventive and calibration maintenance as necessary.
  • Install and validate equipment and processes in the production area to improve yield and/or reduce cycle time following the established validation procedure.
  • Evaluate operating data to conduct on-line adjustments to products, instruments, or equipment. May develop or revise documents and procedures.
  • Modify existing and develop new tooling and fixtures
  • Evaluate and orders necessary equipment, tools and fixtures
  • Work with vendors/suppliers to procure and install tooling, fixtures, and/or equipment
  • Responsible for quality and adheres to manufacturing process requirements, The Resolution Medical Quality Policy. Proactively communicates quality issues and concerns.
  • Understands and applies a solid understanding of Lean Manufacturing and related principles.
  • Assist in implementing new equipment or processes or improving existing ones for cost savings
  • Collect data and perform statistical analysis for process characterization and scrap reduction goals.
  • Work with Process Development to bring new products into production
  • Work with departmental customers to improve material quality and delivery
  • Train and provide technical support or direction to product builders and other technicians
  • Work cross-functionally with project teams and other functions within the company
  • Actively participates in continuous improvement activity.
  • Understands, follows and promotes all Resolution policies and procedures.
  • Observes and complies with all safety rules and regulations.

Requirements

Education, Experience, Required Skills

  • High School Diploma or GED required, 2-year technical degree in a related course of study preferred.
  • 10+ years catheter experience in increasingly technical roles in a medical device manufacturing environment.
  • Prior experience in a regulated industry preferred.
  • Must have knowledge of medical components or device manufacturing
  • High level of manual dexterity and mechanical aptitude
  • Catheter equipment knowledge RF tipping, reflow ovens, vertical laminators, split die bonders, laser bonders, UV curing, adhesive dispensers, hot boxes etc.
  • Possess basic computer skills.
  • High-level understanding of blueprints, drawings and 3D CAD
  • Continuous drive for process improvement and initiative to solve problems.
  • Strong understanding of Resolution Medical quality standards in accordance with ISO 13485
  • Understands cause and effect as it pertains to process, product and manufacturing development
  • Works with a positive attitude and acts within the company’s guiding principles
  • Strong technical ability
  • Ability to work well with teams
  • Motivated with a strong attention to detail
  • Strong written and oral communication skills
  • 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 solve problems, work under pressure, and to effectively manage stress

Physical Requirements

  • Prolonged periods sitting at a desk and working on a computer or microscope
  • Prolonged periods of standing
  • Must be able to lift up to 25 pounds at times
  • Possess the manual dexterity to process components and machines as directed
  • Must have excellent hand-eye coordination
  • Follow gowning procedures and work in a cleanroom environment

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 $40.00-50.00/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.
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