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QTS Medical Device Outsourcing · 1 day ago

Manufacturing Engineer II or III - NPI

Bloomington, MN

Full-time

Onsite

Mid, Senior Level

$75K/yr - $136K/yr

3+ years exp

QTS Medical Device Outsourcing offers critical end-of-line services for medical device OEMs. They are seeking a Manufacturing Engineer II or III to develop and execute project plans for sourcing, cleaning, assembling, packaging, labeling, and sterilizing new medical devices.

Medical Device

Responsibilities

Develop, maintain, and improve procedures, documentation, tools, fixtures, and programs for end-of-line manufacturing of new and existing medical devices, based on external customer specifications

Work closely with Project Managers to assist with planning, cost estimation, and timeline development for defined projects

Interface with Quality to integrate new products or processes into the existing production area

Initiates and completes technical activities leading to new or improved products or design for manufacturability or 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

Identify the root cause of manufacturing process and product nonconformities. Identify and implement the necessary actions to correct and prevent recurrence though the corrective and preventative action process

Perform and document process risk analysis (pFMEA) and implement risk mitigations

Develop and implement manufacturing process, business process, and product improvements with minimal supervisory guidance

Maintain and approve device routers and bill of materials

Develop manufacturing processes utilizing statistical process control as appropriate

Maintain and approve manufacturing procedures

Design and coordinate fabrication and implementation of process fixturing or gauging

Specify and lead qualification activities for new packaging and device components

Qualification

Medical Device Industry Experience3D CAD SoftwareProcess ValidationPPAP KnowledgeISO13485/GMP ExperienceLean ManufacturingTeam EnvironmentMicrosoft Office ProficiencyCommunicationDetail Oriented

Required

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

3 – 7 years of experience in the medical device industry

Knowledge of Medical Device part / production process approval processes (PPAP) for medical devices

Experience with cleaning, sterilization, packaging, and/or sealing process validations for terminally sterilized medical devices

Experience working directly with suppliers in a regulated industry

Understanding of 3D CAD software (i.e., ProE, Unigraphics, SolidWorks, etc.)

Excellent communication and influencing skills

High level of energy, personal accountability, and integrity

Detail oriented; checks own work, keeps accurate records, organizes information effectively

Microsoft Office proficiency (Outlook, Word, Excel, PowerPoint, Publisher)

Clear and effective verbal and written communication skills

Ability to work in a fast-paced team environment

Ability to prioritize and communicate with stakeholders

Preferred

Continuing Education; including participation in local chapters, associations, and/or organizations

Experience in an ISO13485/GMP environment

Engineering experience in a manufacturing facility

Manufacturing process design and validation

Manufacturing equipment and fixture/gauge design

Lean manufacturing, including statistical analysis

Manufacturing automation, including electronic visual inspection

Benefits

401k retirement savings plan with a company match contribution

Onsite health clinics

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

A 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