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DHF Engineer – Disposables R&D, Sustaining (NO C2C OR THIRD PARTY)

+ **Location:** Plymouth, MN (55441)- **remote/hybrid but must be local and able to come into the office at least three days a week**

+ **Duration:** Until 12/2026 (contract extension potential)

+ **Type** : W2 contract (NO C2C OR THIRD PARTY)

+ **Pay:** Negotiable depending on direct-related experience up to $30 - $35 an hour

+ **Work Authorization** : Must be currently in the United States with active employment authorization documents without current or future sponsorship.

Essential Duties and Responsibilities:

+ Create new 3rd party supplier documentation including design specifications, labeling, design drawings, etc. for peritoneal dialysis disposable sets.

+ Create, modify, and maintain design history files.

+ Perform change control assessments.

+ Work closely with project manager and technical lead to achieve project commitments.

+ Adhere to design control procedures, general safety rules, company policies and procedures, FDA and international regulations and guidance.

Qualifications:

+ Experience working with external manufacturing partners and supplier relations.

+ Experience creating and modifying medical device design outputs including receiving and inspection criteria.

+ Experience in medical device product support and change control management.

+ Experience in design transfer from R&D to manufacturing.

+ Working knowledge of FDA Design Controls and ISO 13485 Quality Management Systems.

+ Working knowledge of ANSI/AAMI/ISO 14971 Medical Devices - Application of Risk Management to Medical Devices.

+ Takes initiative with a high aptitude for learning, innovation, and implementing best practices and continuous improvements.

+ Strong attention to detail, organized, and able to independently manage multiple priorities.

Experience and/or Background

+ BS in Mechanical, Plastics, Biomedical Engineering or a related field, MS preferred.

+ 3 - 5 years of related experience in Class II or Class III disposables medical product development.

+ Design for Six Sigma (DFSS) training or certification preferred.

Important information:** **To be immediately considered, please send an updated version of your resume to [email protected].

_*** (Kelly does not expense relocation/interview costs)**_

**Work Authorization** : Must be currently in the United States with active employment authorization documents.

As part of our promise to talent, Kelly supports those who work with us through a variety of benefits, perks, and work-related resources. Kelly offers eligible employees voluntary benefit plans including medical, dental, vision, telemedicine, term life, whole life, accident insurance, critical illness, a legal plan, and short-term disability. As a Kelly employee, you will have access to a retirement savings plan, service bonus and holiday pay plans (earn up to eight paid holidays per benefit year), and a transit spending account. In addition, employees are entitled to earn paid sick leave under the applicable state or local plan. Click here (https://www.mykelly.com/help-support-working-with-kelly-us/#Benefits) for more information on benefits and perks that may be available to you as a member of the Kelly Talent Community.

Why Kelly ® Engineering?

Your engineering skills are in demand, but how do you find the right fit? Easy. At Kelly Engineering, our team creates expert talent solutions to solve the world’s most critical challenges. We connect you with leading organizations where you can collaborate on innovative projects, work with cutting-edge technologies and accelerate your growth. Whether you prefer the variety and flexibility of short-term projects or are looking for a long-term opportunity, we’re here to guide you to the next step in your engineering career.

About Kelly

Work changes everything. And at Kelly, we’re obsessed with where it can take you. To us, it’s about more than simply accepting your next job opportunity. It’s the fuel that powers every next step of your life. It’s the ripple effect that changes and improves everything for your family, your community, and the world. Which is why, here at Kelly, we are dedicated to providing you with limitless opportunities to enrich your life—just ask the 300,000 people we employ each year.

Kelly is committed to providing equal employment opportunities to all qualified employees and applicants regardless of race, color, sex, sexual orientation, gender identity, religion, national origin, disability, veteran status, age, marital status, pregnancy, genetic information, or any other legally protected status, and we take affirmative action to recruit, employ, and advance qualified individuals with disabilities and protected veterans in the workforce. Requests for accommodation related to our application process can be directed to the Kelly Human Resource Knowledge Center. Kelly complies with the requirements of California’s state and local Fair Chance laws. A conviction does not automatically bar individuals from employment. Kelly participates in E-Verify and will provide the federal government with your Form I-9 information to confirm that you are authorized to work in the U.S.

Kelly Services is proud to be an Equal Employment Opportunity and Affirmative Action employer. We welcome, value, and embrace diversity at all levels and are committed to building a team that is inclusive of a variety of backgrounds, communities, perspectives, and abilities. At Kelly, we believe that the more inclusive we are, the better services we can provide. Requests for accommodation related to our application process can be directed to Kelly’s Human Resource Knowledge Center. Kelly complies with the requirements of California’s state and local Fair Chance laws. A conviction does not automatically bar individuals from employment.