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Cretex Medical · 13 hours ago

Manufacturing Engineer II

Anoka, MN

Full-time

Onsite

Mid Level

$74K/yr - $110K/yr

3+ years exp

rms Company, part of the Cretex Medical family, provides contract manufacturing of high-quality medical implants and components. The Manufacturing Engineer II will lead product manufacturing and implement improvements in cost, manufacturability, and quality, while supporting efficient operations in the production area.

Health CareManufacturingMedicalMedical Device

No H1B

Responsibilities

Initiate and complete technical activities leading to new or improved processes for current and next generation programs and to meet strategic goals and objectives of the company

Analyze and solve problems from basic engineering principles, theories and concepts through to a wide range of complex and advanced problems which require novel and innovative approaches or a breakthrough technology

Interfaces with quality and manufacturing to integrate new products or processes into the existing production area

Maintain and approve device routers and bill of materials

Monitor performance of equipment, machines, and tools and corrects equipment problems or process parameters that produce non-conforming products, low yields or product quality issues

Maintain and approve manufacturing procedures

Design and coordinate fabrication and implementation of process fixturing or gauging

Resolve non-conformances and participates on Material Review Board

Analyze and map processes, assesses efficiency, and implements complex project activities

Assist with part cost estimation

Support and comply with the company Quality System, ISO, and medical device requirements

Read, understand, and follow work instructions and standard work

Partner with other business segments: sales/marketing, customer service, engineering, quality, and finance

Understand customer needs and the core business markets we serve

Ensure business systems are implemented, maintained, and functioning properly

Participate in required company meetings

Maintain an organized work area (5S)

Participate in the Operational Excellence Program

Complete all other work duties as assigned

Ability to work in a manufacturing environment

Qualification

Manufacturing process designISO13485/GMP experienceLean manufacturing3D CAD softwareManufacturing automationMaterialsProject managementTeam dynamic skillsStatistical software

Required

Bachelor's Degree in Mechanical, Industrial, or other Engineering Science

3 years of engineering experience in a manufacturing setting; including state of the art manufacturing technology/concepts and cost reductions

Manufacturing process design and validation

Manufacturing equipment and fixture/gauge design

Experience in an ISO13485/GMP environment

Engineering experience with medical devices

Lean manufacturing experience

Knowledge of materials and related processes

Project management experience

DOE, SPC, FMEA, GMP, QSR

Manufacturing automation, including electronic visual inspection

3D CAD software (i.e. ProE, Unigraphics, Solidworks, etc.)

Benefits

Medical, dental, vision and life insurance options

401(k) retirement plan with employer match

Profit sharing

Short- and long-term disability insurance

Paid time off

Holiday pay

Onsite medical clinic

Onsite Clinic

Paid Parental Leave

Monthly Social Events

Annual Employee Appreciation Week

Volunteer Opportunities

Training and Development Opportunities

Tuition Reimbursement

Wellness Program

Discretionary holiday bonus program (based on years of service)

Cretex University

24/7 employee assistance program with access to five confidential visits with a licensed counselor at no cost

Wellness program with incentives

Employee death benefit

Employee sick and safe leave

Comprehensive medical insurance with access to virtual providers

Dental insurance (Little Partners Dental benefit covers services 100 percent for children 12 and younger when seen by a Health Partners in network provider)

Vision insurance

Pre-tax health savings account

Healthcare and dependent care pre-tax reimbursement accounts

Paid holidays

Paid time off

Discretionary profit sharing program

Parental Leave

Accident and critical illness benefits

Optional employee, spouse, and child life

Short and long term disability

Company provided life insurance

Tuition assistance programs