Design And Development Quality Technician II

This position is eligible for a $3,000 sign on bonus.

This position is located on-site based out of our corporate headquarters in Brooklyn Park, MN.

ABOUT THE COMPANY

Cirtec Medical is more than just another design shop or contract manufacturer, we offer a uniquely comprehensive range of vertically integrated capabilities. Cirtec Medical specializes in complex, difficult to produce components and devices in todays most advanced product technologies including, neuromodulation, implantable drug delivery, cardiac rhythm management, ventricular assist and interventional devices and delivery systems. We have the capabilities needed to bring products to full production, including assembly, packaging and testing, and in-house sterilization.

Our employees have the expertise needed to design innovative devices, solve complex design challenges, and help bring our customers devices to market. If you are interested in working in a fun, challenging, fast-paced environment with a company that is growing and providing leading edge technology, Cirtec is the company for you!

YOU ARE A PART OF:

The Engineering team consists of engineers with diverse backgrounds and expertise. The Engineering team works in close collaboration with Operations, R&D, and Purchasing. You will be involved in the design, development, documentation and validation of new customer products, and modification of existing products including defining requirements, timelines, and deliverables with a focus on prototypes, process development, design verification, clinical builds, training production, and preparation for process validation and manufacturing transfer of products.

JOB SUMMARY

This position is primarily responsible for assisting Design & Development engineers on new product introductions. Individual responsibilities to be assigned at the discretion of the Supervisor.

ESSENTIAL RESPONSIBILITIES

Route Engineering Change Orders (ECOs) within Cirtec PLM system.

Responsible for communicating with customer for obtaining ECO approvals.

Write and edit process and procedural documentation as required.

Utilize inspection equipment (VMM, CMM, micrometer, drop indicator, microscope, etc.) to inspect prototype and early development parts and assemblies

Support development with DHR reviews.

Interact when needed with customers and suppliers in support of engineering and production.

Assist in maintaining documentation.

Support the implementation of continuous improvement initiatives for the Document Control System as part of the Quality Management System

Audit support for third party audits and customer audits.

Ability to meet internal and external customer deadlines.

Operates effectively and maintains professionalism in an environment of deadlines and high

workloads and adjusts schedule or work hours to meet changes in priorities.

Able to perform the above duties with little to no supervision.

Complies with company, quality and safety standards, policies, and procedures.

Other duties as assigned.

This is not a remote position.

An individual in this position must be able to successfully perform the essential duties and responsibilities listed above. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions of this position.

QUALIFICATIONS

Associates of Science or equivalent, preferably in an engineering discipline, or a combination of education and relevant work experience.

Minimum 3 years experience in medical/manufacturing environment (Quality experience preferred).

Strong computer skills, including the MS Office (Word, Excel, Outlook) suite.

Above average oral and written communication skills.

Basic knowledge of engineering principles and technical writing.

Ability to interpret technical drawings and technical documents.

Must be able to read, write and speak fluent English.

WHAT WE OFFER

• A fast-paced work environment

• Paid time off

• 401(k) retirement savings with a company match

• Clean, and well-lit production areas

• Training and career development, with onboarding programs for new employees and tuition assistance

• Financial security through competitive compensation, incentives and retirement plans

• Health care and well-being programs including medical, dental, vision, wellness and occupational health programs

WORKING ENVIRONMENT

Work is performed in an office environment. The noise level in the work environment is usually moderate. The work environment characteristics described here are representative of those an individual encounters while performing the essential functions of this position.

EEO STATEMENT

Cirtec Medical Corporation is an Equal Opportunity Minority/Female/Individuals with

Disabilities/Protected Veteran and Affirmative Action Employer

Cirtec Medical Corporation considers for employment and hires qualified candidates without regard to

age, race, religion, color, sex, sexual orientation, gender identity, national origin, ancestry, protected

veteran or disability status or any factor prohibited by law. Cirtec Medical Corporation and all of its related companies fully endorse equal opportunity for all. Cirtec Medical provides reasonable accommodation for qualified individuals with disabilities and disabled veterans in the job application process.